Health Canada Regulatory News
Latest regulatory updates, standard revisions, and guidance publications in the medical device compliance space.
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
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
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
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
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
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
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
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