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REGULATORY INTELLIGENCE · US

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.

  • Sep 24, 2026MATERIAL

    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…

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  • Sep 24, 2026MATERIAL

    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…

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  • Sep 24, 2026MATERIAL

    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…

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  • Sep 23, 2026MATERIAL

    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,…

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  • Sep 23, 2026MATERIAL

    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 …

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  • Sep 23, 2026MATERIAL

    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…

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  • Sep 18, 2026MATERIAL

    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…

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  • Sep 18, 2026MATERIAL

    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 …

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  • Sep 17, 2026MATERIAL

    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…

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  • Sep 17, 2026MATERIAL

    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 …

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  • Sep 17, 2026MATERIAL

    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…

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  • Sep 16, 2026MATERIAL

    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,…

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  • Sep 16, 2026MATERIAL

    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…

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  • Sep 16, 2026MATERIAL

    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…

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  • Sep 14, 2026MATERIAL

    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…

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  • Sep 10, 2026MATERIAL

    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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  • Sep 10, 2026MATERIAL

    Health Canada issues safety alert for GE Healthcare Centricity High Acuity Anesthesia systems over two display and reporting defects

    Health Canada published a safety alert on September 10, 2026 covering GE Healthcare Centricity High Acuity systems affected by two distinct software defects. The affected components are the order and recording summary di…

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  • Sep 10, 2026MATERIAL

    Health Canada flags Beckman Coulter analyzer software defect causing silent unit reversion in plasma chemistry testing

    Health Canada issued a medical device recall alert on September 10, 2026 covering Beckman Coulter DxC 500i and DxC 500 AU Clinical Chemistry Analyzers. A software defect silently reverts user-configured measurement units…

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  • Sep 10, 2026MATERIAL

    Health Canada recall issued for mislabeled Stryker T2 Alpha intramedullary nail locking screws with incorrect length

    Health Canada posted a recall alert on September 10, 2026 for one lot of Stryker T2 Alpha IMN advanced locking screws confirmed to be incorrectly labeled. The affected product contains a 75mm screw where the label states…

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  • Sep 9, 2026MATERIAL

    Health Canada issues safety alert for Philips mobile C-arm X-ray systems over imaging failure risk

    Health Canada published a safety alert on September 9, 2026 for the Philips Veradius Unity and BV Pulsera Mobile C-Arm systems in 9-inch and 12-inch versions. The alert identifies a defect in which air bubbles in the mon…

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