Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
MHRA Updates List of Medical Devices Granted Exceptional Use Authorisations, Including Cancellations
2026-07-10 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices that have received exceptional use authorisations, along with those whose exemptions have expired or been cancelled. Affected stakeholders include device manufacturers, importers, and healthcare providers who rely on such authorisations for continued market access. Organisations should review the list to confirm the current status of any devices they supply or use, and take immediate action if an authorisation has been revoked to ensure compliance.
Tags: mhra, exceptional_use_authorisation, medical_device_exemption, regulatory_decision, market_access
BLEPHADEMODEX Sterile Skin-Cleaning Wipe: Swissmedic FSCA by Laboratoires Théa
2026-07-10 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for BLEPHADEMODEX, a sterile skin-cleaning wipe manufactured by Laboratoires Théa. The reason for the corrective action has not been specified in the notice. Affected model and lot numbers are not detailed; however, users should immediately quarantine the product and follow the manufacturer's instructions for return or disposal. This action underscores the importance of sterility assurance in medical devices.
Tags: fsca, swissmedic, sterile_wipe, medical_device, recall, laboratoires_thea, blephademodex
Astral 150 Ventilator Recall in Canada Due to Performance Issue Posing Ventilation Loss Risk
2026-07-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for ResMed's Astral 150 ventilator due to a potential internal fan stall that may cause a sudden loss of ventilation therapy. The affected devices are from specific lots distributed in Canada. Users must have an alternate means of ventilation available and contact ResMed to arrange repair or replacement. Healthcare providers should immediately quarantine and identify all impacted units.
Tags: medical_device_recall, ventilator, astral_150
Recall: Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod – Sterility Issue
2026-07-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert for the Phantom® Hindfoot TTC/TC Ball Tipped Guide Rod due to a sterility concern. This device, used in foot and ankle surgeries, may not be sterile and poses an infection risk to patients. Healthcare facilities should immediately quarantine affected units, stop using the product, and follow the manufacturer’s recall instructions for return or disposal.
Tags: medical_device_recall, sterility, health_canada, infection_risk, orthopedic_device
Health Canada Recalls ºM Warmer Medical Device Due to Performance Failure
2026-07-09 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall/alert for the ºM Warmer due to performance issues that may compromise its intended function. The recall affects healthcare facilities and professionals using the device, as the failure could pose risks to patient safety. Users are instructed to immediately stop using the product and follow the manufacturer’s instructions for return or remediation. This safety action is part of a new batch of seven Canadian medical device alerts.
Tags: medical_device_recall, performance_issue, health_canada, patient_safety, warming_device
Swissmedic FSCA: Getinge Disinfection AB Warming Cabinets Model 363 – General-Purpose Drying Cabinet
2026-07-09 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Getinge Disinfection AB's general-purpose drying cabinet, marketed as warming cabinets, model 363. The specific reason for the corrective action is not detailed in the notice, but the manufacturer is taking necessary measures to address a potential safety or performance issue. Affected users should follow the manufacturer's instructions provided through the FSCA and contact Getinge Disinfection AB for further guidance.
Tags: swissmedic, fsca, warming_cabinet
MHRA Updates Guidance on Registering Medical Devices for Great Britain and Northern Ireland Markets
2026-07-08 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has updated its guidance on how to register medical devices for the Great Britain and Northern Ireland markets. Manufacturers and authorised representatives must register their devices with the MHRA before placing them on the market, following class-specific routes and deadlines. The guidance addresses both UKCA and CE marking requirements for Northern Ireland.
Tags: medical_device_registration, mhra_guidance, uk_market_access, regulatory_update
Philips Allura Xper FD10 Interventional X-ray System – Performance Issue Safety Alert
2026-07-08 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding the Allura Xper FD10 interventional X-ray system due to a performance issue that may affect image quality and diagnostic reliability. Affected devices could potentially lead to procedural delays or misdiagnosis. Healthcare facilities should immediately verify their system's status, follow the manufacturer's corrective actions, and report any adverse events. Philips is providing inspection and remediation guidance to impacted users.
Tags: medical_device_recall, imaging_system, performance_issue, philips, health_canada, interventional_radiology
Health Canada Recalls Unauthorised Alice Le System Sleepware Software
2026-07-08 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Alice Le System Sleepware Software, an unauthorised medical device used for sleep diagnostics. The software was found to be sold without the required medical device licence. Healthcare facilities should immediately stop using the product, quarantine it, and follow the manufacturer’s return or disposal instructions. Unauthorised devices may pose unknown risks to patient safety and data integrity.
Tags: unauthorised_device, sleep_diagnostic_software, canada_recall
Two Lots of Omnitrope Human Growth Hormone Injection Recalled in Canada Due to Cracked Cartridges
2026-07-08 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for two specific lots of Omnitrope (somatropin) injectable human growth hormone after receiving reports of cracked cartridges. This defect poses a risk of compromised sterility, potentially leading to infection or reduced efficacy for patients. Healthcare professionals and users are urged to immediately stop using product from the affected lots, quarantine remaining inventory, and contact Sandoz Canada for return and replacement. The recall highlights the importance of robust container integrity for parenteral drug-device combination products.
Tags: recall, cartridge_defect, sterility_risk
Swissmedic FSCA: Comecer IRIS Infusion Pump – Added German Language Version (Model 0246010026)
2026-07-08 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has published a Field Safety Corrective Action for Comecer Netherlands B.V.'s IRIS infusion pump, model number 0246010026. The action was taken to provide a German language version of the device documentation, addressing the risk of use errors among German-speaking users. Affected units should be updated with the new German documents following the manufacturer's instructions.
Tags: swissmedic, fsca, infusion_pump, comecer, german_language, product_correction
Swissmedic Issues FSCA for Philips Allura Stationary Angiographic X-Ray Systems
2026-07-08 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has published a Field Safety Corrective Action (FSCA) for Philips Allura stationary angiographic X-ray systems manufactured by Philips Medical Systems Nederland B.V. The affected models are 722026, 722027, 722028, 722029, 722035, 722038, 722039, and 722058. Although the specific reason for the corrective action was not detailed in the notice, users are required to contact Philips immediately for instructions to ensure safe operation.
Tags: swissmedic, fsca, philips_allura, angiographic_x_ray, medical_device_recall
MHRA Releases Compilation of Field Safety Notices for 29 June – 3 July 2026
2026-07-07 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published its weekly summary of Field Safety Notices (FSNs) issued by medical device manufacturers during 29 June to 3 July 2026. This list covers a range of devices and includes mandatory actions such as recalls, software updates, or device inspections. Healthcare providers, device users, and distributors should review the notices to identify affected products and implement the recommended safety measures immediately.
Tags: field_safety_notice, mhra, medical_device, recall, safety_alert, uk_regulation
Class II Recall of Noritsu Precision Enteral Feeding Pump CP-55E (Enteral Nutrition Infusion Pump) in Japan
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
The PMDA has issued a Class II recall for the Enteral Feeding Pump CP-55E, an enteral nutrition infusion pump manufactured by Noritsu Precision Co., Ltd. This recall addresses a safety-related issue that may affect device performance or labeling. Healthcare facilities using this pump should immediately identify affected units, cease use if instructed, and follow the manufacturer’s corrective actions as detailed in the recall notice.
Tags: class_ii_recall, enteral_feeding_pump, pmda_japan
Philips Japan Recalls Integris Allura Flat Detector, Allura Centron, and Azurion Cardiac X-Ray Fluoroscopic Systems (Class II)
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
Philips Japan has initiated a Class II recall (No. 2-12881) for three stationary digital cardiac X-ray fluoroscopic diagnostic devices: Integris Allura Flat Detector, Allura Centron, and Azurion. This recall addresses a moderate safety risk that may affect device performance or patient safety. Healthcare facilities using these systems should immediately follow the manufacturer's field safety corrective action, which may involve inspection, software update, or part replacement, and contact Philips Japan for guidance.
Tags: philips, allura, azurion, cardiac_x_ray, class_ii_recall, pmda_japan
Class II Recall: Covidien Japan V-Loc90 & V-Loc180 Barbed Suture Closure Devices
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
Covidien Japan has issued a Class II recall (No. 2-12880) for its V-Loc90 and V-Loc180 barbed closure devices, which use polyglycomer and polyglyconate sutures respectively. The recall addresses a potential manufacturing defect that may compromise suture integrity, posing a risk of wound dehiscence or prolonged healing. Healthcare providers must immediately identify and quarantine affected lots, discontinue use, and arrange product return to the manufacturer.
Tags: recall, class_ii, suture, barbed_suture, covidien, pmda
PMDA Class II Recall: Sensitouch Synthetic Rubber Surgical Gloves (Non-Latex) by Toray Medical (Recall No. 2-12879)
2026-07-07 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA issued a Class II recall for Sensitouch synthetic rubber surgical gloves manufactured by Toray Medical Co., Ltd. This moderate-risk recall addresses a potential quality defect that could compromise glove integrity. Healthcare providers must immediately identify and quarantine affected lots, cease use, and follow the manufacturer's return or disposal instructions as detailed in recall notice 2-12879.
Tags: surgical_gloves, class_ii_recall, non_latex, pmda, toray_medical, product_safety
Swissmedic FSCA: BAL Flush Syringe SS, 10 ml by Jiaxing Tianhe Pharmaceutical
2026-07-07 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the BAL Flush Syringe SS, 10 ml (model BAL 464013) manufactured by Jiaxing Tianhe Pharmaceutical Co., Ltd. The specific reason for the corrective action has not been disclosed, but it concerns the pre-filled syringes. Healthcare facilities should identify affected products, quarantine them, and follow the manufacturer's instructions for return or disposal.
Tags: swissmedic, fsca, medical_device, prefilled_syringe, recall
Swissmedic FSCA: Boston Scientific Rapid Refill Continuous Injection System Cholangiography Tubing Set
2026-07-07 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Boston Scientific Rapid Refill Continuous Injection System, specifically the Cholangiography tubing set (GTIN 08714729285151, UPN M00566001). The reason for the corrective action is detailed in the manufacturer's notification. Healthcare facilities should identify affected devices, quarantine them, and follow Boston Scientific’s instructions to mitigate any safety risks.
Tags: swissmedic, fsca, boston_scientific, cholangiography_tubing, medical_device, safety_corrective_action, switzerland
MHRA Updates Guidance on Clinical Investigation Notifications for Medical Devices
2026-07-06 | UK MHRA | Regulation Update | !! MEDIUM
The UK's MHRA has published updated guidance outlining the process for notifying the regulator about planned clinical investigations for medical devices. Sponsors and manufacturers must submit specific notification forms with required documentation before starting a study in the UK. This update ensures clarity on regulatory obligations and patient safety requirements for all parties involved in medical device clinical investigations.
Tags: clinical_investigations, mhra, notification, medical_devices, uk_regulations, guidance_update
Health Canada Recalls Hotline IV Fluid Warmer System & Accessories Due to Performance Concerns
2026-07-06 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert and recall for the Hotline IV Fluid Warmer System and its accessories due to performance issues that may compromise patient safety. Affected devices can fail to deliver fluids at the intended temperature, potentially leading to patient harm. Healthcare facilities should immediately identify and quarantine affected units, discontinue use, and follow the manufacturer's instructions for return or correction.
Tags: medical_device_recall, iv_fluid_warmer, performance_issue, health_canada, safety_alert
Class II Recall of VITROS XT7600, 5600II, 5600, 4600 Clinical Chemistry Analyzers by Ortho Clinical Diagnostics in Japan
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
Japan's PMDA announced a Class II recall (No. 2-12877) for Ortho Clinical Diagnostics' VITROS XT7600, 5600II, 5600, and 4600 discrete clinical chemistry analyzers due to a potential performance issue. Affected devices may produce inaccurate results, necessitating a field correction. Healthcare facilities should immediately follow the manufacturer's notification for inspection, software update, or device replacement to mitigate patient risk.
Tags: pmda, class_ii_recall, vitros, clinical_chemistry_analyzer, ortho_clinical_diagnostics, safety
Class II Recall of Nemuri SCAN (NN-1530) Body Motion Sensor by Paramount Bed
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
Paramount Bed Co., Ltd. has initiated a Class II recall of its Nemuri SCAN (NN-1530) body motion sensor. The recall addresses a potential issue where the sensor may provide inaccurate movement detection, which could affect monitoring of patient sleep and activity. Healthcare facilities and users should stop using affected units and follow the manufacturer's instructions for return or replacement.
Tags: class_ii_recall, body_motion_sensor, paramount_bed, pmda, japan
Paramount Bed Recalls Nemuri SCAN (NN-1530) Body Movement Sensor – Class II
2026-07-06 | Japan PMDA | Safety Communication | !! MEDIUM
The Japanese PMDA has issued a Class II recall (No. 2-12874) for the Nemuri SCAN (NN-1530) body movement sensor, manufactured by Paramount Bed Co., Ltd. The recall addresses a potential malfunction that could result in inaccurate detection of patient movements, posing a moderate safety risk. Healthcare facilities and distributors should immediately check affected devices and contact the manufacturer to arrange inspection and necessary corrective actions.
Tags: pmda, recall, class_ii, body_movement_sensor, paramount_bed, sleep_scan
Swissmedic FSCA: Automated Impella Controller by Abiomed – Models 0042-0040, 0042-0010, 0042-0000 and variants
2026-07-06 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a field safety corrective action (FSCA) for the Automated Impella Controller (AIC) manufactured by Abiomed Inc. The affected devices are intracardiac circulatory assist axial-pump catheter control units with model numbers 0042-0040, 0042-0010, 0042-0000, and their EU/UK variants. While the specific reason is not detailed in the notice, users should consult the manufacturer’s instructions for the required corrective actions to ensure patient safety.
Tags: swissmedic, fsca, impella, heart_pump, abiomed, safety_alert, cardiac_assist
SFDA NCMDR Weekly Safety Update WU2628 Released for 5 July 2026
2026-07-05 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2628, dated 5 July 2026. This report compiles recent medical device safety alerts and field safety corrective actions from manufacturers. Affected stakeholders include healthcare providers, distributors, and patients using the listed devices. All relevant parties should review the full report and implement any recommended actions promptly to ensure patient safety.
Tags: saudi_sfda, ncmdr_weekly, safety_alert, medical_devices
FDA Class I Recall: Insulet Removes Omnipod Pods Insulin Pump Due to Under-Delivery Risk
2026-07-03 | FDA | cdrh_news | !!! HIGH
The FDA has announced a Class I recall for Insulet's Omnipod Pods, used with the Omnipod DASH Insulin Management System, due to a missing cannula or needle that can result in under-delivery of insulin. This poses risks of hyperglycemia, diabetic ketoacidosis, and death. Patients and caregivers must immediately stop using affected lots, contact Insulet for replacements, and transition to an alternative insulin delivery method.
Tags: insulin_pump, class_I_recall, omnipod, diabetes_device, safety_alert, insulet
Abiomed Recalls Impella CP Sets with SmartAssist Due to Potential for Catheter Perforation
2026-07-03 | FDA | cdrh_news | !!! HIGH
Abiomed is recalling its Impella CP with SmartAssist sets after reports of the catheter tip breaking or perforating during insertion, which could lead to serious injury or death. The FDA has classified this as a Class I recall, the most serious type. Health care providers should immediately stop using affected devices and follow Abiomed's instructions for return and replacement. The recall affects certain lots distributed from August 2021 to March 2023.
Tags: recall, class_i, impella_cp, smartassist, heart_pump, abiomed, catheter_perforation
Health Canada Recalls Omni-Tract Surgical Retractor System Due to Sterility Failure
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding the Omni-Tract Surgical Retractor System after identifying a sterility failure that could lead to surgical site infections. Affected products include specific lots of the retractor system; healthcare facilities should immediately quarantine and stop using the devices. Users must follow the manufacturer's recall instructions for return or disposal to mitigate patient risk.
Tags: recall, sterility, surgical_instrument, health_canada
Health Canada recalls DLP Select 3D and Elongated One Piece Arterial Cannulae due to sterility performance issues
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for specific DLP arterial cannulae due to potential sterility concerns that could compromise product performance. Affected devices include DLP Select 3D Arterial Cannula and DLP Elongated One Piece Arterial Cannulae. Healthcare facilities must immediately identify and quarantine affected inventory, discontinue use, and follow the manufacturer’s return or disposal instructions. This safety alert highlights a sterility failure that poses a risk of infection to patients.
Tags: canada_recall, sterility_failure, arterial_cannula, medical_device, safety_alert
Health Canada Recalls Hybrid Hydrophilic Microguidewire Due to Performance Issue
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Hybrid Hydrophilic Microguidewire because of a performance defect. The issue may cause coating separation, wire fracture, or loss of hydrophilicity, potentially leading to vascular injury, embolism, or procedural failure. Healthcare professionals must immediately stop using the affected device, quarantine any inventory, and follow the manufacturer's recall instructions for return or replacement.
Tags: medical_device_recall, safety_alert, microguidewire, canada
Intramedullary Bone Saw Blade Assembly Recalled in Canada Due to Sterility Issues
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Intramedullary Bone Saw Blade Assembly due to a lack of sterility assurance. The affected devices may not be sterile, posing a risk of infection to patients. Healthcare facilities must immediately quarantine and discontinue use of the impacted lots, and contact the manufacturer for return or replacement. This recall is part of a broader safety alert for medical devices.
Tags: medical_device_recall, sterility_issue, bone_saw_blade, health_canada, orthopedic_device
Health Canada Recalls Urinary Catheter Trays with Cliniclean Pericare Wipes Over Performance Concerns
2026-07-03 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for urinary catheter trays that contain Cliniclean Pericare Wipes due to performance deficiencies that may affect their intended cleaning and antiseptic function. Healthcare facilities and patients using these trays are affected. Users should immediately stop using the affected lots, quarantine the products, and contact the supplier for return and replacement.
Tags: medical_device_recall, catheter_tray, performance_issue, cliniclean, health_canada
[Class II] ジーシー ガスレーザー (炭酸ガスレーザ) - 株式会社ジーシー
2026-07-03 | Japan PMDA | Safety Communication | !! MEDIUM
Recall #2-12873: 炭酸ガスレーザ / ジーシー ガスレーザー by 株式会社ジーシー. Type: 医療機器.
Accuray CyberKnife Radiosurgery System and M6 Series Class II Recall in Japan (No. 2-12872)
2026-07-03 | Japan PMDA | Safety Communication | !! MEDIUM
Japan’s PMDA has issued a Class II recall (No. 2-12872) for the CyberKnife Radiosurgery System and CyberKnife M6 Series linear accelerator systems used in stereotactic radiotherapy, manufactured by Accuray Inc. The recall indicates a potential safety issue affecting these devices. Healthcare facilities in Japan operating these systems should immediately contact Accuray for corrective actions and follow the manufacturer’s instructions.
Tags: pmda_recall, class_ii, cyberknife, radiosurgery, linear_accelerator, stereotactic_radiotherapy, accuray
SFDA Hosts Workshops on Medical Device Clinical Trials and Health Tech at GHE
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) organized two specialized workshops at the Global Health Exhibition (GHE) covering clinical trial requirements for medical devices and emerging healthcare technologies. The sessions targeted manufacturers, researchers, and healthcare professionals to enhance understanding of regulatory frameworks and encourage compliant innovation. Key discussions included trial design, ethical standards, and technology integration in the medical device sector.
Tags: clinical_trials, healthcare_technologies, sfda_workshop, medical_devices, regulatory_education
SFDA Signs MoU with AAMI to Enhance Medical Device Standards
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
On July 18, 2023, the Saudi Food and Drug Authority (SFDA) signed a Memorandum of Understanding with the Association for the Advancement of Medical Instrumentation (AAMI) to collaborate on medical device standards. The partnership aims to align Saudi requirements with international best practices, affecting manufacturers seeking market access. Companies should monitor for forthcoming standards updates and guidance from this cooperation to ensure ongoing compliance.
Tags: medical_device_standards, SFDA, AAMI, regulatory_cooperation
SFDA Strengthens Global Standing by Regulating Clinical Studies for Innovative Medical Devices and Supplies
2026-07-03 | Saudi SFDA | Regulation Update | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) is advancing its global regulatory position by organizing and overseeing clinical studies for innovative medical devices and supplies. This initiative aims to foster local clinical research, align with international best practices, and encourage medical device innovation within the Kingdom. Medical device manufacturers, clinical research organizations, and healthcare professionals involved in device trials will be directly affected as the authority reinforces its oversight framework.
Tags: clinical_studies, innovative_medical_devices, sfda, regulatory_oversight
Borderline products: MHRA guidance on determining if your product is a medicine
2026-07-02 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA guidance outlines the decision-making process for classifying products as medicinal products (medicines) versus medical devices or other categories. It covers essential criteria such as product presentation, pharmacological action, and intended purpose. Manufacturers of potentially borderline products should review this guide to ensure proper classification and comply with UK regulatory requirements, avoiding misclassification risks.
Tags: borderline_products, medicine_classification, mhra_guidance, product_classification, medical_device_regulation
Health Canada Alert: Performance Issue with Aisys, Avance, and Aespire Anesthesia Machines
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding a performance issue affecting GE Healthcare's Aisys, Avance, and Aespire anesthesia machines. The recall addresses a potential malfunction that could compromise device performance during use. Healthcare facilities should immediately identify affected units, contact the manufacturer for corrective action, and ensure clinical contingency plans are in place until resolution.
Tags: medical_device_recall, anesthesia_machine, performance_issue, health_canada, safety_alert
Health Canada Issues Performance Alert for RAPIDLab® 348EX Blood Gas System
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert regarding the RAPIDLab® 348EX System, a blood gas analyzer, due to a performance issue that may lead to inaccurate test results. Laboratories and healthcare facilities using this device should immediately verify performance according to the manufacturer's instructions. The alert includes corrective actions to mitigate patient risks and ensure compliance.
Tags: medical_device_recall, performance_issue, blood_gas_analyzer, health_canada
Recall of AirSeal Access Port with Blunt Obturator and Optical Obturator Due to Performance Issue
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for the AirSeal Access Port with Blunt Obturator and the AirSeal Access Port with Optical Obturator. The recall is due to a performance issue that could compromise device functionality during laparoscopic procedures. Healthcare facilities should immediately locate and quarantine affected units, and follow the manufacturer's instructions for return or disposal. This alert aims to prevent potential patient harm associated with the defective access ports.
Tags: medical_device_recall, laparoscopic_access_port, performance_issue, health_canada, safety_alert
Health Canada Recalls Glidesheath Slender® Introducer Sheath Due to Performance Issue
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Glidesheath Slender® Introducer Sheath (Terumo Corporation) due to a performance issue. The device may separate or kink during use, potentially causing vessel injury, prolonged bleeding, or delayed hemostasis. Affected lots must be immediately identified, quarantined, and returned to the manufacturer for replacement.
Tags: medical_device_recall, introducer_sheath, performance_defect
WASPLab Recall: Performance Issue May Impact Specimen Processing – Health Canada Alert
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall alert for the WASPLab automated microbiology system due to a performance issue that could lead to incorrect specimen processing or result errors. Healthcare facilities using affected WASPLab units should immediately verify system performance and follow the manufacturer's instructions. The recall aims to prevent potential misdiagnosis or delayed results. Users are advised to contact the manufacturer for corrective actions.
Tags: medical_device_recall, performance_issue, microbiology_automation, canada_health_alert
LIFECODES LSA Class II
2026-07-02 | Health Canada | Safety Communication | !! MEDIUM
Performance
Health Canada Recalls Fludeoxyglucose (18F) Injection Due to Cracked Vial, Risk of Contamination
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Fludeoxyglucose (18F) Injection due to cracked vials, which pose a risk of compromised sterility and potential infection. This radiopharmaceutical is used in PET imaging, and affected healthcare facilities should immediately quarantine and return the impacted lots. The issue may lead to patient harm if the product is used without assured sterility. Further details on lot numbers and distribution can be found on the Health Canada recall page.
Tags: recall, radiopharmaceutical, product_quality, cracked_vial, health_canada
Health Canada Safety Alert: NephroMax High Pressure Nephrostomy Balloon Catheter Device Compatibility Issue
2026-07-02 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety alert for the NephroMax High Pressure Nephrostomy Balloon Catheter due to a device compatibility issue. This recall affects all healthcare facilities using this catheter in nephrostomy procedures. Users are advised to check compatibility with guidewires and other accessories, and to report any incidents. The manufacturer is providing updated instructions for use.
Tags: recall, balloon_catheter, device_compatibility, safety_alert, health_canada
FSCA: B. Braun Infusomat Space P Single-Channel Infusion Pump (Model 8713070)
2026-07-02 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action for the B. Braun Melsungen AG Infusomat Space P bedside infusion pump, model 8713070. The reason for the corrective action is not detailed in the brief notice, but it signals a potential safety issue requiring user attention. Healthcare facilities using this device should immediately consult the full FSCA on the Swissmedic portal and follow the manufacturer's recommended actions to mitigate any risk.
Tags: swissmedic, fsca, infusion_pump, safety, b_braun, field_safety_corrective_action
Class I Recall: Abiomed, Inc. - Abiomed Impella CP Set with SmartAssist (10th Generation) containing affected 14
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling 168 units of its Impella CP Set with SmartAssist (10th Generation) that contain the affected component 14. The recall was initiated due to the potential for thrombus formation during prolonged use of the introducer. Customers should immediately locate and quarantine the affected sets, discontinue use, and return them to Abiomed as instructed in the firm's Urgent Medical Device Recall notice.
Tags: class_i_recall, abiomed, impella_cp, thrombus, introducer
Abiomed Recalls Impella CP Low Profile Introducer Kit Due to Thrombus Risk – FDA Class I Recall
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. has initiated a Class I recall of its Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP, part of the Impella Set Pro, due to the potential for thrombus formation during prolonged use. The FDA has classified this as the most serious type of recall, indicating a risk of serious injury or death. A total of 17 units are affected. Healthcare providers should immediately stop using the recalled devices, quarantine them, and contact Abiomed for return instructions.
Tags: fda_class_i_recall, abiomed, impella_cp, introducer_kit, thrombus_risk, medical_device
Class I Recall: Abiomed 14 Fr Low Profile Introducer Kit for Impella CP – Thrombus Formation Risk
2026-07-01 | FDA | recall_class1 | !!! HIGH
Abiomed, Inc. is recalling its 14 Fr x 13 cm Low Profile Introducer Kit (used with Impella CP/Impella Set Pro) due to a potential for thrombus formation during prolonged use. This Class I recall, the most serious type, involves only 3 units. Users should immediately quarantine the affected kits and follow the manufacturer’s instructions to prevent possible embolic events.
Tags: class_i_recall, thrombus_formation, impella_cp, abiomed, introducer_kit
Class I Recall: Medline Industries, LP - Medline Convenience Kits: 1) DYNJ905503F, Model Number: CV ANESTHESIA - ROOM
2026-07-01 | FDA | recall_class1 | !! MEDIUM
Recall #Z-2452-2026 by Medline Industries, LP. Reason: The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose Injection, USP which were recalled due to quality. Quantity: 227 units.
MFDS Launches Innovative Medical Product Fast-Track Review with 240-Day Approval Target
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) of South Korea has introduced a new innovation-focused review pathway that aims to complete the approval of cutting-edge medical products within 240 days. This streamlined process targets high-tech medical devices and drugs, reducing regulatory turnaround time and enhancing predictability for sponsors. Manufacturers of innovative products should review the updated submission requirements and prepare for accelerated premarket reviews. The initiative reflects MFDS's commitment to expediting patient access to novel technologies.
Tags: fast_track, approval_timeline, innovation, mfds, regulatory_reform, premarket_review
MFDS Publishes Medical Device Good Manufacturing Practice (GMP) Regulations
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has published the Medical Device Good Manufacturing Practice (GMP) Regulations, establishing quality management system requirements for manufacturers and importers. These regulations cover design, production, installation, and servicing standards to ensure device safety and performance. Stakeholders must align their quality systems with the new rules and prepare for compliance audits by MFDS. Companies distributing medical devices in Korea should review the full text and update their procedures accordingly.
Tags: gmp, quality_management_system, korea_mfds
MFDS Issues Guiding Principles for Clinical Trials of Machine Learning-Enabled Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has published 'Guiding Principles for conducting Clinical Trial for Machine Learning-enabled MDs,' providing a regulatory framework for clinical evaluation of medical devices that incorporate machine learning. This guidance targets manufacturers and sponsors of ML-enabled medical devices, outlining key considerations for trial design, data management, performance assessment, and safety monitoring. Stakeholders are advised to review the principles to ensure their clinical trial protocols align with the new recommendations when seeking regulatory approval in Korea.
Tags: machine_learning, clinical_trial, guidance, medical_device, korea_mfds
MFDS Issues New Regulation on Unique Device Identification (UDI) Management for Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has promulgated a new regulation establishing comprehensive requirements for Unique Device Identification (UDI) management. This rule mandates that medical device manufacturers, importers, and distributors assign and maintain UDI codes, register device identifiers in the integrated database, and comply with phased implementation timelines. The regulation aims to enhance traceability and safety across the device supply chain, requiring affected entities to update labeling, quality systems, and reporting processes accordingly.
Tags: unique_device_identification, udi, medical_device_regulation, korea_mfds, traceability
MFDS Guidance on Additional Considerations for Conformity Assessment of In Vitro Companion Diagnostic Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) of Korea has published a guidance document specifying additional considerations for the conformity assessment of in vitro companion diagnostic medical devices. This affects manufacturers and sponsors of companion diagnostics by detailing supplementary evidence and performance requirements to be addressed during conformity assessment. Regulatory affairs professionals should review the new elements to ensure their technical documentation aligns with MFDS expectations when seeking or maintaining device approvals in Korea.
Tags: companion_diagnostics, ivd, conformity_assessment, mfds_guidance, korean_regulations
MFDS Amends the Enforcement Rule of the Medical Devices Act
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) has revised the Enforcement Rule of the Medical Devices Act. This updated rule contains detailed administrative procedures covering device licensing, clinical investigations, good manufacturing practice, and post-market obligations. All medical device manufacturers, importers, and distributors operating in South Korea must review the changes and align their regulatory compliance processes accordingly. Industry should promptly assess the impact on product registrations, facility requirements, and reporting duties.
Tags: korea_mfds, medical_device_act, enforcement_rule, regulatory_update
MFDS Amends Regulation on Permission, Notification, Review of Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
This amendment updates the comprehensive Korean regulation governing medical device marketing authorization, notification, and review processes. It affects manufacturers and importers seeking to place devices on the Korean market, introducing revised procedures, documentation requirements, and classification criteria. Companies must review the changes to ensure ongoing compliance and adapt their registration dossiers accordingly.
Tags: korea, medical_device_regulation, marketing_authorization, review_procedure, notification
MFDS Issues Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has published the Enforcement Rule of the Act on In-Vitro Diagnostic Medical Devices, detailing the procedures and standards needed to implement the new IVD legislation in Korea. This rule applies to all manufacturers, importers, and distributors of in-vitro diagnostic products. Affected parties should review the rule to comply with requirements on classification, conformity assessment, quality management, and post-market surveillance.
Tags: korea_mfds, ivd_regulation, enforcement_rule, regulatory_update
MFDS Issues Instructions on Labeling and Management of Unique Device Identifiers
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The Ministry of Food and Drug Safety (MFDS) has released a guidance document specifying how medical device manufacturers and importers must label Unique Device Identifiers (UDIs) and manage UDI-related data. The instructions cover label placement, format, and submission requirements to the national UDI database. Affected companies should review and align their labeling and data management processes to meet Korea’s UDI compliance deadlines.
Tags: udi, labeling, medical_devices
MFDS Issues Regulations on Labeling and Description for Medical Devices
2026-07-01 | Korea MFDS | Regulation Update | !!! HIGH
The South Korean Ministry of Food and Drug Safety (MFDS) has published regulations detailing mandatory requirements for the labeling and description of medical devices marketed in Korea. These rules cover product identification, manufacturer information, intended use, warnings, and instructions, affecting all domestic and foreign manufacturers and importers. Companies must review their current labeling and descriptions to ensure full compliance with the updated provisions to avoid regulatory penalties or market access issues.
Tags: labeling, medical_device_regulation, korea_mfds, description_requirements, compliance
MFDS Revises Standards for Medical Device Good Manufacturing Practices (GMP)
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
South Korea's Ministry of Food and Drug Safety (MFDS) has published a revision to the Standards of Medical Device Good Manufacturing Practices. The updated standards align quality management system requirements more closely with international norms such as ISO 13485. Medical device manufacturers and importers in the Korean market must review their quality systems and implement necessary changes to remain compliant. A transition period is expected, and stakeholders should promptly assess the impact on their operations.
Tags: gmp, quality_management_system, korea_mfds, iso_13485, medical_device
MFDS Publishes 2025 Medical Device Approval Report
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) has released its annual report detailing medical device approvals in Korea for 2025, covering certifications, amendments, and market trends. The report serves as a benchmark for manufacturers, importers, and regulatory professionals seeking to understand the Korean medical device approval landscape. No immediate regulatory action is required, but stakeholders are encouraged to review the data for strategic planning and compliance monitoring.
Tags: korea_mfds, medical_device_approval, annual_report, regulatory_affairs
MFDS Publishes 2024 Medical Device Approval Report
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) has issued its annual report for 2024, summarizing medical device approval statistics, including new certifications, amendments, and renewals. The document provides insights into approval volumes, review timelines, and product category trends. Regulatory professionals should examine the report to benchmark submission strategies and monitor shifts in MFDS review practices.
Tags: korea_mfds, medical_device_approval, annual_report, regulatory_intelligence
MFDS Publishes 2023 Medical Device Approval Statistics Report
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Ministry of Food and Drug Safety (MFDS) has released its Annual Medical Device Approval Report for 2023, summarizing the number of product approvals, certifications, and clearances. The data covers domestic and imported devices, providing industry stakeholders with insights into regulatory trends and market access activity. Medical device manufacturers and importers can use this information for benchmarking and strategic planning in the Korean market.
Tags: medical_device_approval, annual_report, MFDS, regulatory_statistics, South_Korea
MFDS Publishes 2022 Medical Device Approval Report with Market Trend Data
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) released the 2022 Medical Device Approval Report, providing annual statistics on approvals, certifications, and notifications. The report details trends by device class and product type, serving as a reference for manufacturers and regulatory professionals to understand Korea’s medical device market dynamics and plan market entry strategies.
Tags: medical_device, korea_mfds, approval_report, annual_statistics, regulatory_intelligence
MFDS Publishes 2021 Medical Device Approval Report and Statistics
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) released the 2021 Medical Device Approval Report, summarizing the year’s approval, certification, and amendment statistics. The report offers insights into approval volumes, timelines, and classification trends, helping regulatory affairs professionals assess market entry dynamics. No immediate compliance actions are required, but the data is valuable for strategic registration planning and benchmarking.
Tags: medical_device, approval_report, mfds, annual_statistics, korea_regulation
MFDS Publishes 2020 Medical Device Approval Report with Annual Statistics
2026-07-01 | Korea MFDS | Regulation Update | ! LOW
The Ministry of Food and Drug Safety (MFDS) has released its annual report on medical device approvals for 2020. The report provides a statistical overview of product registrations, certifications, and approvals, highlighting category trends and market entry volumes. Regulatory professionals and manufacturers can use this data to benchmark approval timelines, identify growth segments, and anticipate regulatory focus areas. No immediate action is required, but the document serves as a valuable resource for strategic planning and compliance monitoring.
Tags: medical_device_approval, mfds_report, market_statistics, 2020_annual_summary
MFDS Released the 2019 Medical Device Approval Report Summarizing Approval Statistics
2026-07-01 | Korea MFDS | Regulation Update | !! MEDIUM
The Korean Ministry of Food and Drug Safety (MFDS) published the 2019 Medical Device Approval Report, providing an overview of medical device approvals, certifications, and classifications for the year. This report is essential for medical device manufacturers, importers, and regulatory professionals to understand market access trends and regulatory activities in South Korea. It includes statistics on approval numbers, product categories, and review timelines, helping stakeholders assess the approval landscape and plan future submissions.
Tags: medical_device_approval, annual_report, korea_mfds
Swissmedic FSCA: Olympus Single Use Distal Cover (MAJ-2315) Patient Protection Cap
2026-07-01 | Swissmedic | Safety Communication | !!! HIGH
Swissmedic has issued a Field Safety Corrective Action (FSCA) for the Olympus Single Use Distal Cover, a single-use endoscope patient protection cap. The affected model is MAJ-2315 and lot N6192000. While the specific reason for the corrective action was not detailed in the notification, users should immediately identify and quarantine affected products and follow Olympus' instructions to mitigate potential risks.
Tags: swissmedic, fsca, olympus, distal_cover
Swissmedic FSCA for SY-LAB IceCube Linear Rate Medical Freezers
2026-07-01 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for SY-LAB IceCube medical freezers with linear rate control, affecting models 11XS MED, 14S MED, 14M MED, 17M MED, 17L MED and their non-MED variants. The specific safety reason was not published in the initial notice. Users in laboratories and healthcare settings should immediately review the full FSCA on the Swissmedic portal and follow the manufacturer's corrective measures.
Tags: swissmedic, fsca, medical_freezer, laboratory_equipment, safety_correction
EC Publishes Delegated Acts on Well-Established Technologies Under EU MDR
2026-06-30 | EU MDR/IVDR | Regulation Update | !!! HIGH
The European Commission has published new delegated acts concerning well-established technologies (WET) under the Medical Devices Regulation (MDR). This update affects manufacturers of specific Class IIb implantable and Class III devices, such as sutures, staples, and bone screws, by clarifying exemptions for clinical investigations. Affected manufacturers must review the updated acts upon entry into force to verify their eligibility for WET exemptions and adjust their clinical evaluation strategies accordingly.
Tags: eu_mdr, delegated_act, well_established_technologies, clinical_evaluation
View Source (European Commission)
FDA Title 21 CFR Update: Medical Device Parts 800-898 Revised (June 26, 2026)
2026-06-30 | FDA | Regulation Update | !! MEDIUM
The FDA has updated Title 21 of the Code of Federal Regulations (CFR), with the latest revision dated June 26, 2026. This update potentially affects medical device regulations under Parts 800-898. Regulatory affairs professionals should review the amended sections to ensure ongoing compliance for medical device manufacturing, labeling, and quality systems.
Tags: fda, cfr_title_21, medical_device_regulations
UK MHRA Publishes Field Safety Notices for 22–26 June 2026
2026-06-30 | UK MHRA | Safety Communication | !! MEDIUM
This item lists 10 field safety notices (FSNs) issued by medical device manufacturers during the week of 22–26 June 2026, as compiled by the UK MHRA. It alerts healthcare professionals, patients, and regulatory affairs teams to potential safety issues and required corrective actions. Affected parties should immediately review the notices, identify relevant devices, and implement any field safety corrective actions. The compilation is part of the MHRA's routine safety communication.
Tags: field_safety_notice, mhra, medical_device_safety
MHRA Safety Roundup – June 2026: Latest Safety Advice for Medicines and Medical Devices
2026-06-30 | UK MHRA | Safety Communication | !! MEDIUM
This June 2026 roundup from the UK MHRA consolidates the latest safety updates for both medicines and medical devices. Healthcare professionals, patients, and device users should review the listed warnings, recalls, and guidance to ensure continued safe use. The document highlights key actions including checking affected products and reporting adverse incidents through the Yellow Card scheme. It serves as a monthly compliance resource for vigilance and risk management.
Tags: mhra, safety_roundup, medical_devices, medication_safety, post_market_surveillance
MHRA Field Safety Notices compilation for 22–26 June 2026: 6 new device alerts published
2026-06-30 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA released a weekly list of six Field Safety Notices issued between 22 and 26 June 2026. Healthcare professionals and medical device organisations should review the notices to identify any relevant safety actions, such as software updates, part replacements, or usage modifications, and implement manufacturer instructions promptly to maintain patient safety and regulatory compliance.
Tags: field_safety_notice, mhra, medical_device_safety, regulatory_alert, postmarket_surveillance
FSCA for Medline MEDSTOP Stopcock: New Language Added to Labeling
2026-06-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a field safety corrective action for the MEDSTOP stopcock manufactured by Medline Industries LP. The corrective action involves adding a new language to the device labeling to meet regulatory requirements. Affected models are identified by their Field Safety Notice (FSN). Distributors and healthcare facilities should ensure the updated labeling is used.
Tags: stopcock, labeling_update, field_safety_corrective_action, medline, swissmedic
MHRA Issues Updated Guidance on Borderline Products: Medical Devices vs Other Products
2026-06-29 | UK MHRA | Regulation Update | !! MEDIUM
The UK MHRA has published updated guidance on borderline products, explaining the principles used to decide whether a product is a medical device and whether the Medical Devices Regulations 2002 apply. The document provides examples, flowcharts, and case studies to help manufacturers determine if their product falls under medicines, cosmetics, food, or general product safety regulations instead. Stakeholders should use this guidance to ensure correct classification and regulatory compliance in the UK market.
Tags: borderline_products, medical_device_classification, mhra_guidance, uk_regulations
Health Canada Safety Alert: Abiomed Introducer Kits with Impella Heart Pumps – Performance Issue
2026-06-29 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a safety recall/alert for specific Abiomed Introducer Kits used with Impella heart pumps due to a performance issue. The performance defect may impact device insertion, function, or patient safety during cardiac procedures. Affected healthcare facilities should immediately check the Health Canada alert, identify and quarantine the recalled lots, and follow the manufacturer’s instructions for return or disposal.
Tags: medical_device_recall, impella_heart_pump, performance_issue
Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innova
2026-06-29 | Singapore HSA | Regulation Update | !! MEDIUM
HSA Speeches: Keynote Address by Adj Prof (Dr) Raymond Chua, Chief Executive Officer, Health Sciences Authority, on "Regulatory Innovation as a Catalyst for Global Medtech Growth" for Singapore Medical Device Ventu
SFDA NCMDR Weekly Safety Update WU2627 – Medical Device Field Safety Notices and Recalls
2026-06-28 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) National Center for Medical Devices Reporting (NCMDR) published Weekly Update WU2627 on 28 June 2026, compiling new field safety corrective actions and recalls for medical devices. Healthcare facilities and distributors should review the listed devices and affected manufacturers to identify products requiring action and implement the recommended safety measures. The update covers multiple device categories and includes details on risk mitigation steps.
Tags: saudi_sfda, ncmdr, weekly_update, safety_notice, recall
MHRA Guidance: Registering Medical Devices for the Great Britain and Northern Ireland Markets
2026-06-26 | UK MHRA | Regulation Update | !! MEDIUM
This MHRA guidance outlines the process for registering medical devices before they can be placed on the market in Great Britain and Northern Ireland. It applies to manufacturers, authorised representatives, and responsible persons, who must ensure all devices are properly registered under the UK Medical Devices Regulations 2002. Key steps include identifying the correct registration route, submitting required device information, and maintaining compliance with post-market obligations. Failure to register can result in enforcement action and prevent lawful sale.
Tags: medical_device_registration, mhra, market_access, uk_compliance
[Alert] Product Alert of Dexcom US G7 Sensors: Lots 1725204004 and 1725069002
2026-06-25 | New Zealand Medsafe | Safety Communication | !! MEDIUM
Medsafe Alert - Product: Device
Argon Medical Devices L-Cath™ PICC and Midline Catheters Recall Due to Performance Issue
2026-06-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for Argon Medical Devices' L-Cath™ PICC and Midline Catheters due to a performance issue that may affect catheter function. The affected devices could pose risks such as catheter breakage, leakage, or failure during use, potentially leading to patient harm. Healthcare facilities should immediately identify and quarantine impacted lots, and follow the manufacturer's instructions for return or disposal.
Tags: canada_recall, picc_catheter, midline_catheter, performance_issue, argon_medical
Health Canada Issues Recall for UHI-4 High Flow Insufflation System Insufflator Due to Performance Problems
2026-06-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the UHI-4 High Flow Insufflation System Insufflator due to performance issues that may compromise device function. The recall affects all healthcare facilities using this insufflator in laparoscopic or endoscopic procedures. Users should immediately quarantine affected units, identify all stock, and contact the manufacturer for corrective actions. No adverse events have been confirmed at this time, but the device may present a risk to patient safety if performance degradation occurs during surgery.
Tags: medical_device_recall, insufflator, performance_failure, health_canada, surgical_safety
Health Canada Recalls Abbott's Infinion™ CX Contact Lead Kit Over Performance Concerns
2026-06-24 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Infinion™ CX Contact Lead Kit, a component of Abbott's spinal cord stimulation system, due to performance issues that may compromise device functionality. Affected products include all lots of the lead kit, which are used by healthcare providers to deliver neuromodulation therapy. The recall advises immediate identification and quarantine of unused kits, along with enhanced monitoring of patients already implanted with the lead. This alert is part of a broader update involving 10 new medical device recalls in Canada.
Tags: medical_device_recall, neuromodulation, lead_kit, performance_issue, canada_safety_alert
MHRA Field Safety Notices: 15-19 June 2026 – 10 New Notices Published
2026-06-23 | UK MHRA | Safety Communication | !! MEDIUM
This item aggregates 10 field safety notices issued by the UK MHRA between 15 and 19 June 2026. The notices cover various medical devices requiring corrective actions or safety communication from manufacturers. Healthcare providers and device manufacturers must review the list to identify affected products and implement any mandated actions to ensure patient safety and regulatory compliance.
Tags: field_safety_notices, mhra, medical_device_safety, post_market_surveillance, regulatory_compliance
UK MHRA Weekly Field Safety Notices Compilation: 15–19 June 2026
2026-06-23 | UK MHRA | Regulation Update | !! MEDIUM
This item lists all Field Safety Notices (FSNs) issued by the UK MHRA between 15 and 19 June 2026, covering post-market safety actions for medical devices and IVDs. It affects manufacturers, healthcare providers, and users who must review the notices for relevant corrective actions. Key actions include identifying affected devices in inventory, implementing manufacturer instructions, and reporting any incidents.
Tags: field_safety_notices, mhra, medical_device_safety
MHRA Decision: List of Medical Devices Granted Exceptional Use Authorisations
2026-06-23 | UK MHRA | Regulation Update | !! MEDIUM
The MHRA has published an updated list of manufacturers and medical devices that have been granted exceptional use authorisations. The list also includes devices whose exemptions have expired or been cancelled. Affected manufacturers, importers, and healthcare providers should review the list to verify the current status of relevant products and ensure continued compliance with the applicable conditions of the authorisation.
Tags: exceptional_use, mhra_authorisation, medical_devices, regulatory_update
Health Canada Recalls Hoffmann® II Carbon Connecting Rod Due to Performance Issue
2026-06-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Hoffmann® II Carbon Connecting Rod, an orthopaedic implant component, due to performance issues that may compromise device functionality and patient safety. Affected healthcare facilities and surgeons must immediately cease use of the recalled devices and follow the manufacturer's return or disposal instructions. This safety alert underscores the need for prompt inventory quarantine and adherence to adverse event reporting protocols.
Tags: medical_device_recall, performance_issue, orthopaedic_implant, health_canada
Recall of A.T.S® 4000 TS Tourniquet Systems with CPC Connectors Due to Sterility Concerns
2026-06-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for A.T.S® 4000 TS Tourniquet Systems single and dual hose models with CPC connectors. The recall is due to potential sterility issues that may compromise patient safety. Healthcare facilities using these devices should immediately identify affected units, discontinue use, and follow the manufacturer’s return or disposal instructions. This safety alert is part of a broader set of Canadian medical device recalls.
Tags: tourniquet, sterility, safety_recall, medical_device, canada
Health Canada Recalls Optima XR240amx X-Ray System Due to Performance Issue
2026-06-23 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the Optima XR240amx X-Ray System due to a performance issue that may affect image quality or system reliability. Healthcare facilities using this device should immediately consult the recall notice and follow the manufacturer's corrective actions. Affected users must verify device status and may need to suspend use until remediation is completed. The alert is part of a wider set of medical device safety actions in Canada.
Tags: medical_device_recall, x_ray_system, canada
Health Canada Recalls CyberKnife® Treatment Delivery System Due to Performance Issues
2026-06-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a recall for the CyberKnife® Treatment Delivery System, manufactured by Accuray, due to performance issues that could lead to inaccuracies in radiation treatment delivery. Affected healthcare facilities must immediately follow the manufacturer's instructions for inspection, mitigation, and possible device repair or replacement. Users should contact the manufacturer to confirm if their system is impacted and implement necessary corrective actions to ensure patient safety.
Tags: medical_device_recall, radiation_therapy, performance_issue, canada, safety_alert
Health Canada Recalls Penumbra System RED 68 Reperfusion Catheter Due to Performance Issue Risking Tip Separation
2026-06-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued a medical device recall for the Penumbra System RED 68 Reperfusion Catheter due to a performance issue that may cause the catheter tip to separate or detach during use. The affected catheter is used in neurovascular thrombectomy procedures to remove blood clots from cerebral arteries. Healthcare professionals are advised to immediately quarantine and discontinue use of the recalled lots, and return them to Penumbra. This recall addresses a risk of serious adverse events, including vessel damage, embolism, or stroke.
Tags: medical_device_recall, performance_issue, catheter_tip_separation, neurovascular, class_i_recall, health_canada
Health Canada Recalls Gyrus ACMI Classic Series Continuous Flow Resectoscope Due to Sterility Issue
2026-06-22 | Health Canada | Safety Communication | !!! HIGH
Health Canada has issued an alert/recall for the Gyrus ACMI Classic Series Continuous Flow Resectoscope after a sterility issue was identified that could compromise device safety. Affected devices may not be sterile, posing an infection risk to patients during urological or gynecological procedures. Healthcare facilities should immediately quarantine the affected units, cease use, and follow the manufacturer's instructions for return or disposal. Prompt action is required to prevent potential patient harm.
Tags: medical_device_recall, sterility, resectoscope
SFDA NCMDR Weekly Update (WU2626) – Medical Device Safety Alerts and Adverse Event Reports
2026-06-21 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) released Weekly Update WU2626 through the National Center for Medical Devices Reporting (NCMDR), detailing recent safety alerts, adverse event reports, and field safety corrective actions concerning medical devices in the Saudi market. Healthcare providers, importers, and manufacturers should review the listed devices and implement any recommended actions to ensure patient safety and regulatory compliance.
Tags: medical_devices, safety_alert, sfda, ncmdr, weekly_update, saudi_arabia
Commission Implementing Decision (EU) 2026/1231 -- Updated Harmonised Standards for MDR
2026-06-17 | EU MDR/IVDR | Regulation Update | !!! HIGH
Published 17 June 2026 (effective 11 June 2026), this decision amends Decision 2021/1182 and updates harmonised standard references across nine medical device categories: biological evaluation (EN ISO 10993-12:2021/A1:2025), labelling/symbols (EN ISO 15223-1:2021/A1:2025), electromedical equipment, transfusion equipment, ophthalmic optics, non-active surgical implants, washer-disinfectors, prostheses, and sharps injury protection. Manufacturers must review technical documentation, declarations of conformity, and test reports against updated standard references.
Tags: harmonised_standards, biological_evaluation, labelling, conformity
Accuray CyberKnife Xchange Collimator Changer Recalled: Collimator Docking Failure May Cause Injury
2026-06-16 | FDA | Safety Communication | !!! HIGH
Accuray Incorporated is recalling its CyberKnife Treatment Delivery System with Xchange Robotic Collimator Changer due to a risk that a collimator may not fully dock. If personnel enter the treatment room and use the in-room control pendant after a docking interlock, the collimator could fall, posing a serious injury hazard. Users must follow the manufacturer's corrective actions, including not attempting manual motion when the interlock is active.
Tags: recall, radiation_therapy, collimator, safety, linear_accelerator, medical_device
Accuray CyberKnife with Xchange Collimator Changer Recalled for Collimator Docking Failure Hazard
2026-06-16 | FDA | Safety Communication | !!! HIGH
The FDA announced a recall of Accuray's CyberKnife Treatment Delivery System equipped with the Xchange Robotic Collimator Changer. If a collimator does not fully dock, a system interlock may be triggered; should personnel then manually move the robot using the in-room pendant, the collimator could fall, risking injury to patients or staff. Users should immediately inform all operators of this risk and adhere to the manufacturer's interim safety instructions until a permanent correction is deployed.
Tags: device_recall, radiation_oncology, collimator_failure, patient_safety, fda_recall
FARADRIVE Steerable Sheath: Swissmedic FSCA for Added Language to Labeling
2026-06-16 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for Boston Scientific's FARADRIVE Steerable Sheath, a single-use vascular guide-catheter. The reason is the addition of a new language to the product labeling, categorized as a correction. Affected models are referenced in the FSN; users should update and follow the revised instructions for use.
Tags: swissmedic, fsca, labeling_update, steerable_sheath, boston_scientific
Alerta 5265 (Tecnovigilância) - Comunicado da empresa Zimmer Biomet Brasil Ltda - Sutura MaxBraid.
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5265 (Tecnovigilância) - Comunicado da empresa Zimmer Biomet Brasil Ltda - Sutura MaxBraid.
Alerta 5264 (Tecnovigilância) - Comunicado da empresa Olympus Optical do Brasil Ltda - Unidade de Insuflação de Alto Flu
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5264 (Tecnovigilância) - Comunicado da empresa Olympus Optical do Brasil Ltda - Unidade de Insuflação de Alto Flu
Alerta 5263 (Tecnovigilância) - Comunicado da empresa Elekta Medical Systems Comércio e Serviços Radioterapia Ltda - Sis
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5263 (Tecnovigilância) - Comunicado da empresa Elekta Medical Systems Comércio e Serviços Radioterapia Ltda - Sis
Alerta 5262 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Azurion (10216710345); Equipamento
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5262 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Azurion (10216710345); Equipamento
Alerta 5261 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Arco Cirúrgico Zenition.
2026-06-16 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5261 (Tecnovigilância) - Comunicado da empresa Philips Medical Systems Ltda - Arco Cirúrgico Zenition.
MHRA Weekly Field Safety Notices: 8-12 June 2026
2026-06-15 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA published the compilation of Field Safety Notices (FSNs) issued between 8 and 12 June 2026. These notices alert healthcare professionals and users to safety issues with medical devices and medicinal products, requiring actions such as product checks, modifications, or recalls. Manufacturers and responsible persons should review the list to identify any notices relevant to their products and ensure compliance with required actions. This weekly update is part of MHRA’s routine safety surveillance.
Tags: uk_mhra, field_safety_notice, safety_surveillance
Alerta 5260 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hos
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5260 (Tecnovigilância) - Comunicado da empresa GE Healthcare do Brasil, Com. e Serv. para Equipamentos Médico-Hos
Alerta 5259 (Tecnovigilância) - Comunicado da empresa Randox Brasil LTDA - Controle de Urinálise.
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5259 (Tecnovigilância) - Comunicado da empresa Randox Brasil LTDA - Controle de Urinálise.
Alerta 5258 (Tecnovigilância) - Comunicado da empresa Siemens Healthcare Diagnósticos Ltda - Reagente Flex Tacrolimus (T
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5258 (Tecnovigilância) - Comunicado da empresa Siemens Healthcare Diagnósticos Ltda - Reagente Flex Tacrolimus (T
Alerta 5257 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos médicos LTDA -
2026-06-15 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5257 (Tecnovigilância) - Comunicado da empresa VR Medical Importadora e Distribuidora de Produtos médicos LTDA -
SFDA NCMDR Weekly Safety Update WU2625 – 14 June 2026
2026-06-14 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority (SFDA) National Center for Medical Devices Reporting (NCMDR) has released Weekly Update WU2625 on 14 June 2026. This report contains recent adverse event notifications, field safety corrective actions, and recall notices for medical devices marketed in Saudi Arabia. Healthcare providers and device manufacturers should review the listed affected products and implement any required risk mitigation measures as specified in the update.
Tags: saudi_fda, ncmdr, medical_device_safety, weekly_report, recall_alert
Alerta 5256 (Tecnovigilância) - Comunicado da empresa Conmed do Brasil Comercio, Imp. e Exp. de Produtos Médicos Hospita
2026-06-12 | Brazil ANVISA | Safety Communication | !! MEDIUM
Alerta 5256 (Tecnovigilância) - Comunicado da empresa Conmed do Brasil Comercio, Imp. e Exp. de Produtos Médicos Hospita
Recall: Zimmer Surgical Sterile Tourniquet Hoses (A.T.S 4000 TS) – Potential Sterility Breach (Recall Z-2673-2026)
2026-06-09 | FDA | Safety Communication | !!! HIGH
Zimmer Surgical has initiated a recall (Z-2673-2026) of its A.T.S 4000 TS Tourniquet Systems Dual Hose with CPC Connectors due to a potential sterility breach in the sealing area of the sterile pouch. Use of affected devices could lead to moderate localized infection requiring treatment; if the issue is noticed before use, it may cause a clinically insignificant delay while an alternative device is obtained. Healthcare providers should immediately identify and quarantine all affected units, stop using them, and return them to the manufacturer as instructed.
Tags: device_recall, sterility_breach, tourniquet_hoses, zimmer_surgical
Zimmer Surgical Recalls A.T.S 4000 TS Tourniquet Single Hose Over Potential Sterility Breach
2026-06-09 | FDA | Safety Communication | !!! HIGH
The FDA has announced a recall of Zimmer Surgical's A.T.S 4000 TS Tourniquet Systems Single Hose with CPC Connectors (Recall Z-2674-2026) due to a potential sterility breach in the sealing area of the sterile pouch. If the affected device is used, it may lead to moderate localized infection; if discovered prior to use, it may cause a clinically insignificant extension of surgery while an alternative is sourced. Healthcare providers should immediately identify and quarantine all affected units.
Tags: recall, sterility_breach, tourniquet_hose, zimmer_surgical, infection_risk
FDA Recalls Siemens ARTIS icono ceiling Due to Risk of Monitor Detachment from Ceiling Suspension
2026-06-08 | FDA | Safety Communication | !!! HIGH
The FDA has issued a Class I recall (Z-2648-2026) for the Siemens ARTIS icono ceiling angiography system (model 11328100) due to a potential issue with the Display Ceiling Suspension (DCS Fix XL). Over time, screws securing the monitor to the suspension may gradually loosen, causing the monitor to detach and fall, posing a risk of impact injury to patients or healthcare staff. Affected facilities should immediately inspect the suspension assembly and contact Siemens to arrange for corrective maintenance.
Tags: fda_recall, siemens_medical_solutions, artis_icono_ceiling, ceiling_suspension, loose_screws, safety_alert
MHRA Field Safety Notices for 1–5 June 2026 Now Available
2026-06-08 | UK MHRA | Safety Communication | !! MEDIUM
The UK MHRA has published the weekly list of Field Safety Notices (FSNs) for 1–5 June 2026. This compilation affects healthcare providers and organisations using affected medical devices in the UK. Users should review each notice and take recommended actions to address potential safety issues with specific devices.
Tags: field_safety_notice, mhra, medical_devices, uk_regulation, safety_alert
SFDA NCMDR Weekly Update WU2624 (07 June 2026) Issued
2026-06-07 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2624 on 07 June 2026. This report summarizes recent medical device safety alerts, listing affected products and manufacturers. Healthcare providers and stakeholders should review the update to identify any necessary corrective actions or field safety notices relevant to their facilities.
Tags: saudi_fda, ncmdr, weekly_update, safety_alert
Medela Recalls ENFit ExSet Syringes Due to Incompatible Connectors Risking Enteral Feeding Delays
2026-06-05 | FDA | Safety Communication | !!! HIGH
Medela Inc. is recalling its ENFit ExSet Strl 60 2.0ml PV 1ct EN syringe (Model ENF060182LD / 101033086) because the product may contain incorrect connectors that cannot attach or misconnect to ENFit connections. This incompatibility could cause a slight delay in the delivery of enteral nutritional fluids or oral medication. Healthcare providers and patients should immediately identify affected units, discontinue use, and follow the firm's instructions for return or disposal.
Tags: recall, enteral_feeding, connector_safety, fda, medela
Device Recall: Remel, Inc - GC Agar Base (150mm) 10/PK R04030; GC Agar Base (100mm) 10/PK R01460
2026-06-03 | FDA | Safety Communication | !! MEDIUM
Recall Z-2623-2026: Reduced or no recovery of some strains of Neisseria gonorrhoeae.
MDCG 2026-4: Management of SS(C)P in EUDAMED After Mandatory Use
2026-06-02 | EU MDR/IVDR | New Guidance | !!! HIGH
Published June 2026, MDCG 2026-4 transfers SSCP/SSP upload responsibility from Notified Bodies to manufacturers in EUDAMED. Key dates: from 28 May 2026 Notified Bodies continue uploading during transition; from October 2026 manufacturers take over direct upload; deadline 27 February 2027 for devices already on market. Manufacturers must upload master SS(C)P and translations, ensuring the uploaded version matches the one validated during certification.
Tags: eudamed, sscp, notified_body, manufacturer_obligation
View Source (European Commission)
NMPA Announcement No. 52 (2026) -- Medical Device Classification Adjustment Procedures
2026-06-01 | NMPA | Regulation Update | !!! HIGH
Published 1 June 2026, this announcement clarifies transitional procedures when medical device management categories or attributes are adjusted. Covers: registration/filing requirements when classification changes from higher to lower class; transition from medical device to non-medical device status; timeline and documentation requirements for affected manufacturers.
Tags: classification, registration, transition, compliance
Swissmedic FSCA: Armstrong Medical PEP Therapy APL Valve – Language Addition to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic Field Safety Corrective Action (FSCA) concerns the APL Valve used in Positive Expiratory Pressure (PEP) Therapy Devices from Armstrong Medical Limited. The reason for the correction is the addition of a new language to the device labeling, likely to meet local regulatory language requirements. Affected models are listed in the Field Safety Notice (FSN). No direct patient safety issue is involved; users should follow the updated labeling instructions.
Tags: swissmedic, fsca, medical_device, labeling_update, pep_therapy, armstrong_medical, apl_valve
Swissmedic FSCA: Armstrong Medical Adult Coaxial Breathing Systems APL Valve - Added Language to Labeling
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic FSCA addresses Armstrong Medical Limited's Adult Coaxial Breathing Systems, specifically the APL valve. The corrective action adds a new language to the device labeling or instructions for use, ensuring compliance with Swiss official language requirements. Affected models are detailed in the related Field Safety Notice (FSN). Users should verify they have the updated labeling and follow the manufacturer's instructions.
Tags: swissmedic, fsca, breathing_system, armstrong_medical, labeling_update, apl_valve, language
Swissmedic FSCA: Armstrong Medical Resuscitation Sets (Mapleson Systems) – APL Valve Labeling Language Update
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
This Swissmedic field safety corrective action addresses Armstrong Medical Limited's Resuscitation Sets (Mapleson Systems) where the APL valve labeling required a new language addition. Affected models are listed in the Field Safety Notice (FSN). Users are advised to consult the FSN and ensure the updated labeling is integrated into the instructions for use. This is a documentation correction, not a safety defect.
Tags: swissmedic, fsca, labeling_correction, resuscitation_set, armstrong_medical
Swissmedic FSCA: Paediatric Ayres T‑Piece Systems – APL Valve Label Updated with New Language
2026-05-28 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for Armstrong Medical Limited's Paediatric Ayres T‑Piece Systems (Resuscitation Set) affecting the APL Valve. The corrective action involves adding a new language to the device labelling to ensure proper use. Affected models are detailed in the Field Safety Notice (FSN); users should review the updated instructions and share the notice with relevant personnel.
Tags: swissmedic, fsca, medical_device, labeling_correction, pediatric_resuscitation, apl_valve
SFDA NCMDR Weekly Safety Update WU2622 (24 May 2026) Released
2026-05-24 | Saudi SFDA | Safety Communication | !! MEDIUM
The Saudi Food and Drug Authority's National Center for Medical Devices Reporting (NCMDR) has published Weekly Update WU2622, dated 24 May 2026. This report compiles recent field safety notices, recalls, and adverse event reports affecting medical devices registered in the Kingdom. Manufacturers, authorized representatives, and healthcare providers should review the listed alerts to identify any devices within their inventory and implement required corrective actions promptly.
Tags: sfda, ncmdr, weekly_safety_update, field_safety_notice, medical_device_recall
Swissmedic Expands °M Warmer FSCA: 7 More Lots Affected for MEQU A/S Blood/Fluid Warmer
2026-05-11 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has updated the Field Safety Corrective Action (FSCA) for MEQU A/S's °M Warmer, a conduction blood/fluid warmer, expanding the affected scope to include 7 additional lots. The correction applies to models MWS201 (Box of 5) and MWS201W (Single in Silver Pouch). Users should identify impacted devices and follow the manufacturer's instructions provided in the original FSCA notice.
Tags: swissmedic, fsca, blood_fluid_warmer, mequ, lot_expansion
Swissmedic FSCA: Staar Surgical AG IOD Software – New Information for Ophthalmology Instruments
2026-04-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic has issued a Field Safety Corrective Action (FSCA) for IOD Software, a software accessory manufactured by Staar Surgical AG used with various ophthalmology instruments. The corrective action stems from new information about the software, though affected model or lot details are not specified. Users of the impacted software should follow recommended actions such as applying updates or contacting the manufacturer to maintain safe and effective operation.
Tags: swissmedic, fsca, ophthalmology, software
GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes
2026-04-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-02-R8 Annex 1 Declaration for dealing with MD that are solely for export or re-export purposes (2026 Apr)
Swissmedic FSCA: Sphere-9 Catheter – Updated Field Safety Notice (Medtronic/BIOTRONIK)
2026-03-30 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic issued a Field Safety Corrective Action for the Sphere-9 Catheter (Model AFR-00001), manufactured by Medtronic, Inc. and BIOTRONIK SE & Co. KG. The reason is a new version of the Field Safety Notice (FSN) for this cardiac tissue ablation device. Affected users should review the updated FSN and implement any revised instructions.
Tags: fsca, cardiac_ablation_catheter, field_safety_notice
NMPA Announcement No. 21 (2026) -- UDI Full Coverage Implementation Timeline
2026-03-13 | NMPA | Regulation Update | !!! HIGH
Published 13 March 2026, jointly issued by NMPA, National Health Commission and National Healthcare Security Administration. Mandates UDI implementation for all remaining medical device categories: all Class II devices and Class I IVDs by 1 June 2027; all Class I devices by 1 June 2029. Manufacturers must complete UDI assignment, data upload and maintenance. Provincial drug regulatory authorities are to coordinate with health and healthcare security departments to promote integration.
Tags: udi, traceability, full_coverage, multi_department
NMPA Announcement No. 15 (2026) -- UDI Exemption for Specific Circumstances
2026-03-13 | NMPA | Regulation Update | !! MEDIUM
Published 13 March 2026, defines 7 circumstances where medical devices are exempt from UDI implementation: clinical trial devices, custom-made devices, device components, post-market study devices, and others. For reusable devices where direct marking may affect safety, UDI must be marked on the smallest sales unit packaging with alternative traceability solutions.
Tags: udi, exemption, clinical_trial, custom_device
GN-15-R13 Guidance on Medical Device Product Registration
2026-03-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-15-R13 Guidance on Medical Device Product Registration (2026 Mar)
FDA Revised Cybersecurity Guidance for Medical Devices (Feb 2026)
2026-02-03 | FDA | New Guidance | !!! HIGH
Issued 3 February 2026, superseding the June 2025 version. Aligns with the new QMSR and ISO 13485. Applies to all devices with cybersecurity considerations, not just network-connected devices. Key expectations: Secure Product Development Framework (SPDF), threat modeling, Software Bill of Materials (SBOM), eight security control categories (authentication, authorization, cryptography, integrity, confidentiality, event detection, resiliency, updatability), and coordinated vulnerability disclosure processes.
Tags: cybersecurity, premarket_submission, software, sbom
QMSR Takes Effect -- 21 CFR Part 820 Incorporates ISO 13485:2016
2026-02-02 | FDA | Regulation Update | !!! HIGH
Effective 2 February 2026, the FDA's Quality Management System Regulation (QMSR) amends 21 CFR Part 820 by incorporating ISO 13485:2016 by reference. The legacy Quality System Inspection Technique (QSIT) was discontinued and replaced by Compliance Program 7382.850, aligned with ISO 13485. Manufacturers must now explicitly comply with ISO 13485:2016 requirements. Two older guidance documents (1997 design control guidance and 2008 PMA manufacturing inspection guidance) were withdrawn.
Tags: quality_management, iso_13485, cgmp, inspection
Follow-up Field Safety Notice for ORBIS Medication 3.x by DH Healthcare GmbH
2026-01-23 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a follow-up Field Safety Corrective Action (FSCA) for ORBIS Medication 3.x, a medical device software from DH Healthcare GmbH. This notice provides additional information supplementing previously issued Field Safety Notices (FSNs). Affected model numbers are not specified in the notice. Users should review the updated safety information and follow the manufacturer’s recommendations.
Tags: swissmedic, fsca, field_safety_notice, follow_up, medical_device_software, dh_healthcare, orbis_medication
Zimmer Tourniquet Systems: Field Safety Corrective Action for Serial Number Update (Models 60500010100, 60320010100)
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Zimmer Surgical, Inc. has issued a Field Safety Corrective Action (FSCA) for the Zimmer Tourniquet Systems concerning models 60500010100 and 60320010100. The reason is to update serial numbers, which may involve correcting records or labeling to maintain traceability. Affected users should follow the manufacturer’s instructions to verify and update the serial numbers as required.
Tags: swissmedic, fsca, tourniquet_system, serial_number_update, zimmer_surgical
Zimmer Tourniquet Systems Serial Number Update – Swissmedic FSCA
2026-01-20 | Swissmedic | Safety Communication | !! MEDIUM
Swissmedic published a Field Safety Corrective Action for Zimmer Surgical's pneumatic tourniquet systems (models 60500010100, 60320010100). The corrective action is to update serial numbers, likely due to labeling or documentation discrepancies. Affected users should follow manufacturer instructions to verify and update the serial numbers; no product recall or return is required.
Tags: swissmedic, fsca, zimmer_surgical, tourniquet_system, serial_number_update
GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach
2025-12-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GL-04-R4 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2025 Dec)
GN-34 R2 Guidance for IVD Analysers
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-34 R2 Guidance for IVD Analysers (2025 Oct)
GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-17 R4 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2025 Oct)
GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT
2025-10-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GN-18 R4 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2025 Oct)
GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs)
2025-09-01 | Singapore HSA | Regulation Update | !! MEDIUM
HSA medical device guidance update: GL-08-R2 Regulatory Guidelines for Laboratory Developed Tests (LDTs) (2025 Sep)
[Alert] Stop using Euky Bear Warm Steam Vaporiser - model number EBSV2013
2025-05-30 | New Zealand Medsafe | Safety Communication | !! MEDIUM
Medsafe Alert - Product: Device