Health Canada Drugs & Medical Devices
Material regulatory developments from Health Canada are tracked daily by Cresthaven Analytics. Over the last 90 days, 20 material briefs relevant to professionals operating in the healthcare & life sciences sector have been published below. Each brief is sourced directly from the primary regulatory feed, summarized for institutional readers, and scored for materiality.
Recent material activity
Health Canada recall targets LIFEPAK 35 defibrillators over improperly seated port connectors affecting device reliability
Health Canada issued a recall alert on September 4, 2026 for Stryker's LIFEPAK 35 Monitor/Defibrillator after the manufacturer identified that printer and modem access port connectors may not be fully seated within the r…
Read the full Health Canada Drugs & Medical Devices brief →Boston Scientific recalls Imager II Angiographic Catheters over tip detachment risk from manufacturing defect
Health Canada posted a medical device removal notice on September 4, 2026, covering Boston Scientific's Imager II Angiographic Catheters. A manufacturing deficiency reduced stabilizing agent levels in catheter tips, rais…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall issued for Gore VIABAHN Endoprosthesis over distal tip bonding defect identified in quality control
Health Canada posted a recall alert on September 4, 2026 for the Gore VIABAHN Endoprosthesis with PROPATEN Bioactive surface after Gore identified through quality control testing that some devices were processed using eq…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall covers Balt Extrusion intracranial stent system over bacterial endotoxin non-conformance
Health Canada posted a voluntary recall by Balt Extrusion on September 2, 2026, covering specific lots of the LEO+ Intracranial Self Expandable Stent and Delivery System. The recall stems from non-conforming bacterial en…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for Stryker LIFEPAK 35 defibrillator over missing inconclusive-rhythm display prompt
Health Canada posted a safety alert on September 2, 2026 for the Stryker LIFEPAK 35 Monitor/Defibrillator. The alert identifies a nonconformance in which the device fails to display the 'CHECK RHYTHM / ECG Analysis Incon…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall orders immediate discontinuation of Olympus BiCOAG Hemostasis Probe over ceramic tip detachment risk
Health Canada recalled the Olympus BiCOAG Hemostasis Probe on September 2, 2026, after Olympus determined that affected units may have been manufactured with insufficient adhesive securing the ceramic tip. Detachment of …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall issued for Quantum PureFlow heat exchanger over blood contamination risk during cardiac procedures
Health Canada issued a recall alert on September 2, 2026, for the Quantum PureFlow Standard Heat Exchanger High Flow device after confirmed blood-to-glycol leakage during clinical use. The failure allows blood to contami…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of JAMP Temozolomide 140 mg capsules for out-of-specification active ingredient
Health Canada published recall RA-82571 on August 31, 2026, covering one lot of JAMP Temozolomide 140 mg capsules distributed by JAMP Pharma Corporation. The affected lot, RLTS0225A, fails assay specification for temozol…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues field safety notice for Gentherm Blanketrol temperature management devices over circuit board overheating
Health Canada published a field safety notice on August 28, 2026 covering the Blanketrol II 115V and Blanketrol III 115V patient temperature management systems distributed by Gentherm Medical. The notice confirms a 0.53%…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of Carestation 850 anesthesia systems over unexpected shutdown risk
Health Canada issued a Type II recall on August 28, 2026 of Datex-Ohmeda Carestation 850 and 850C anesthesia systems under recall identification RA-82535. The recall addresses unexpected device shutdown upon loss or disc…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of Apo-Semaglutide lot 700059A over eightfold overdose delivery risk
Health Canada published recall RA-82536 on August 27, 2026, covering Apotex Inc.'s Apo-Semaglutide Injection lot 700059A under DIN 02568020. The affected lot may display and deliver a 2 mg dose instead of the prescribed …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets Automated Impella Controller purge flag failures across all Canadian units
Abiomed has initiated a voluntary recall of the Automated Impella Controller (AIC) in Canada after a rise in complaints about purge cassette recognition failures caused by degradation of the purge flag component. The rec…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall flags UDI mislabeling on Pro+ Flat Deck Wide surface model p7924a13 over bed frame incompatibility risk
Health Canada issued a recall alert on August 27, 2026 for the Pro+ Flat Deck Wide W/O X-Ray, model p7924a13, because an incorrect UDI label states the wrong product description and an incompatible bed frame width. The l…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall issued for Cardinal Health surgical packs containing leaking Stryker StrykeFlow PS handpieces
Health Canada published a recall on August 27, 2026 for Cardinal Health Gynaecology Robotics and Endoscopy Packs containing the Stryker StrykeFlow PS handpiece. The recall addresses a pattern of complaints reporting flui…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets ICU Medical IV sets over drip chamber discoloration affecting CHS Ltd. manufactured devices
Health Canada's recalls portal published an alert on August 26, 2026 covering certain ICU Medical Canada IV administration sets affected by visible discoloration in the drip chamber. CHS Ltd., which incorporates these IV…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recalls BioFire Joint Infection Panel 30-Pack over KPC false-positive contamination risk
Health Canada issued a recall alert on August 26, 2026 for the BioFire Joint Infection Panel 30-Pack after KPC nucleic acid contamination in the outer primer pellet produced false-positive results. The contamination affe…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of GE Healthcare CARESCAPE Central Station over patient monitoring gap after restart
Health Canada published recall RA-82531 on August 26, 2026, covering GE Healthcare CARESCAPE Central Station v3.0.x under catalogue numbers 5867474-03 and 5867474-04. Affected units may fail to resume patient monitoring …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada field safety corrective action targets Maquet percutaneous insertion kits over sterile barrier failures across all in-shelf-life units
Health Canada published a Field Safety Corrective Action on August 26, 2026, covering all in-shelf-life Maquet Percutaneous Insertion Kit and Dilator Set products after the manufacturer identified failures in sterile bar…
Read the full Health Canada Drugs & Medical Devices brief →Cynosure Lutronic issues safety alert for DermaV laser system over patient burn risk from spark events during vascular treatment
Health Canada issued a safety alert on August 26, 2026 for the Cynosure Lutronic DermaV laser system after identifying an adverse complaint trend across North America. Reported events include sparks, loud noise, and pati…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type I recall of two unauthorized herbal liquids containing undeclared sildenafil distributed in Ontario
Health Canada published a Type I recall on August 25, 2026 covering Twins Herbal Idakole and Twins Herbal Pelorie, both liquid products sold without a Drug Identification Number by Twins African Restaurant and Bar Inc. B…
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