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
A selection of recent published briefs; this is not a complete archive.
Health Canada monitors Sanofi-Aventis Canada recall of 1,043 insulin units across approximately 80 distribution points
Sanofi-Aventis Canada Inc. voluntarily recalled 1,043 insulin pen and cartridge units on September 25, 2026, after identifying a risk that affected stock may have frozen during shipping. The recall covers multiple lots d…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recalls nine Sarclisa vials from Nova Scotia over potential freeze damage during shipment
Health Canada issued a Type I recall on September 25, 2026, covering nine units of Sarclisa (isatuximab, 500 mg/25 mL, Lot 5F028A) distributed to three locations in Nova Scotia. Sanofi-aventis Canada Inc. initiated the r…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recalls Ethicon PERMA-HAND Silk Suture over unauthorized chemical contamination in primary packaging
Health Canada recalled Ethicon PERMA-HAND Silk Suture on September 25, 2026, after the manufacturer confirmed that affected lots were incorrectly packaged with a tubing fluid — containing isopropyl alcohol, diethylaminoe…
Read the full Health Canada Drugs & Medical Devices brief →Abbott updates Amulet Left Atrial Appendage Occluder IFU to address pulmonary artery injury risk
Health Canada published a safety communication on September 25, 2026 regarding Abbott's Amplatzer Amulet Left Atrial Appendage Occluder. Abbott is revising the device's instructions for use to explicitly identify the pul…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada safety alert flags premature battery drain in Stryker Inzone Detachment System affecting coil delivery function
Health Canada published a safety alert on September 24, 2026 covering Stryker's Inzone Detachment System following observations of premature battery drain. Affected devices may fail to power on, present diminished indica…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada Drugs & Medical Devices release pending Cresthaven Analytics full analysis: InterStim™ Systems
Health Canada Drugs & Medical Devices published a regulatory release titled 'InterStim™ Systems'. Cresthaven Analytics' full intelligence brief is pending re-analysis; see the source link below for the complete primary t…
Read the full Health Canada Drugs & Medical Devices brief →Baxter issues urgent correction for Likorall ceiling-mounted patient lift systems over double-fault drop risk
Baxter Corporation issued an urgent correction on September 24, 2026 for the Likorall ceiling-mounted patient lift system. The correction targets a double-fault failure scenario in which simultaneous motor shaft breakage…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of IMAAVY solution over glass particle contamination in two lots
Health Canada published recall RA-82660 on September 21, 2026, covering two lots of IMAAVY 300 mg/1.62 mL solution (Janssen Inc.) distributed nationally across healthcare establishments. The recall is classified Type II,…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets Medtronic OmniaSecure MRI SureScan model 3930M lead over driveshaft separation and fracture risk
Health Canada issued a safety alert on September 23, 2026 for the Medtronic OmniaSecure MRI SureScan model 3930M transvenous cardiac lead. The alert concerns a manufacturing adhesive defect: insufficient adhesive at the …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets Cook Medical cystoscopic injection needles over manufacturing defect in luer lock adapter
Health Canada issued a recall alert on September 23, 2026, for Cook Medical's Williams Cystoscopic Injection Needle, covering affected device lots with a manufacturing defect. The female luer lock adapter may be incorrec…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada warns clinics of counterfeit Soprano-brand laser devices carrying falsified medical device licences
Health Canada issued a public advisory on September 18, 2026 identifying counterfeit laser hair removal and therapy devices sold under the Soprano brand to Canadian clinics. Beijing Perfectlaser Technology Co., Ltd. supp…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for GE Healthcare SIGNA Artist MRI systems over arc flash injury risk to service personnel
Health Canada published a safety alert on September 18, 2026 for the GE Healthcare SIGNA Artist and SIGNA Artist Evo MRI systems. An exposed sharp edge inside the electronics cabinet may damage power cables, creating an …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets RAPICIDE PA High Level Disinfectant lots over blocked-vent bottle swelling and user exposure risk
Health Canada published a recall alert on September 17, 2026 for STERIS RAPICIDE PA High Level Disinfectant. Specific Part A lots are affected: blocked bottle vents may cause swelling and chemical exposure when the produ…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets Trinity Biotech Oxalate Reagent B lot over falsely low patient results
Health Canada issued a recall on September 17, 2026 for Trinity Biotech Oxalate Reagent B, Product Code 591-2, Lot 2500711. The cited defect is performance variability causing negative bias and under-recovery of oxalate …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for Philips MRI systems exporting incorrect diffusion tensor imaging data
Health Canada published a safety alert on September 17, 2026 covering Philips Ingenia, Achieva, and Intera MR systems. The alert identifies a defect in the Enhanced MR DICOM export format that produces incorrect diffusio…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type III recall of Platinum Naturals Easymulti Stress Men capsules for Vitamin B6 mislabelling across four lot numbers
Health Canada published recall RA-82628 on September 16, 2026, covering Platinum Naturals Easymulti Stress (Men) capsules under lots 737, 737A, 737B, and 737C. The affected lots state an incorrect quantity of Vitamin B6,…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall targets NDI Passive Spheres with reflective coating defect affecting surgical navigation tracking
Health Canada published a medical device recall on September 16, 2026 covering NDI Passive Spheres from affected sterile lots with identified variation in their infrared-reflective outer coating. The defect may cause ins…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada flags incorrect fluid-balance calculations in Philips IntelliSpace Critical Care and Anesthesia releases J.06.01 and J.06.02
Health Canada issued a medical device safety alert on September 16, 2026 covering Philips IntelliSpace Critical Care and Anesthesia (ICCA) software releases J.06.01 and J.06.02. The alert identifies a defect in which inf…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada updates TZIELD product monograph to add contraindications and viral reactivation screening requirements
Health Canada, in collaboration with sanofi-aventis Canada Inc., issued a safety communication on September 14, 2026 updating the Canadian Product Monograph for TZIELD (teplizumab). The update adds a contraindication for…
Read the full Health Canada Drugs & Medical Devices brief →Teva Canada recalls one lot of Novo-Gesic Forte 500 mg acetaminophen over phenolic resin or epoxy contamination risk
Health Canada announced on September 10, 2026 that Teva Canada Limited is recalling one lot of Novo-Gesic Forte 500 mg acetaminophen tablets distributed to pharmacies in 1,000-count bottles. The recall stems from potenti…
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