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 safety alert identifies ECG waveform and heart-rate calculation defects in IQecg Digital ECG plugin software
Health Canada published a safety alert on October 19, 2026 for the IQecg Digital ECG plugin software, identifying a defect that may produce incorrect ECG waveforms and inaccurate heart-rate calculations. The alert covers…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type I recall of Dantrium Intravenous lots for particulate matter contamination
Health Canada has issued a Type I recall for three lots of Dantrium Intravenous (dantrolene sodium for injection), marketed by Knight Therapeutics Inc., due to particulate matter contamination. The recall applies nationa…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of GE SIGNA Architect MRI system over incorrect liver stiffness measurements
Health Canada issued a Type II recall for the GE Medical Systems SIGNA Architect MRI system, serial number PG75M2300263SC, due to incorrect liver stiffness measurements generated by the MR Touch protocol on certain MR sy…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada posts Stryker alert for NICO Myriad Paediscope handpiece adapter fit failure
Health Canada published a recall alert on October 16, 2026 for the NICO Myriad 19x21.5 MHP Paediscope (model NN-8520) across four identified lot numbers. Stryker identified that the handpiece may not fit through the incl…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Class 4 recall of ARCHITECT i2000SR Processing Module over electrical arcing risk
Health Canada has posted a Class 4 recall for the ARCHITECT i2000SR Processing Module, affecting units equipped with the optional Induction Heater Control Module. The recall identifies a 5 Amp diode in that module that m…
Read the full Health Canada Drugs & Medical Devices brief →Cochlear Limited recalls CI1012 implants over open-circuit electrode pathway risk
Cochlear Limited is recalling a limited number of CI1012 Cochlear Implants, announced October 15, 2026. A potential condition has been identified that, if present, could cause one or more open circuits affecting individu…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada posts Siemens Healthineers recall alert for EMIT 2000 Quinidine Assay over precision failures exceeding validated specifications
Health Canada published a recall alert on October 15, 2026 for the Siemens Healthineers EMIT 2000 Quinidine Assay following confirmed precision failures on the DXC 700 AU and Viva-ProE analyzers. Repeatability coefficien…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues field safety notice for cobas c 303 analytical unit over tubing failure and erroneous result risk
Health Canada published a field safety notice on October 15, 2026 for the Roche cobas c 303 analytical unit, identifying premature deterioration of vacuum tubing in the cell rinse unit. Tubing rupture can cause undetecte…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recalls HemosIL AcuStar HIT-IgG(PF4-H) Lot B38062 over negative analytical bias and calibration failures
Health Canada recalled HemosIL AcuStar HIT-IgG(PF4-H) Lot B38062 on October 15, 2026. This diagnostic reagent detects heparin-induced thrombocytopenia antibodies. The recall addresses two performance defects in affected …
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for Medtronic CareLink SmartSync Device Manager over Bluetooth disconnection risk during cardiac device programming
Health Canada published a safety alert on October 14, 2026 for the Medtronic CareLink SmartSync Device Manager, identifying Bluetooth disconnections that may cause undesirable or incomplete parameter programming during p…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for Philips Allura Xper Systems over FlexVision software failure during clinical use
Health Canada published a safety alert on October 14, 2026 for Philips Allura Xper Systems after Philips identified a software defect in the FlexVision display application. The defect causes the display to become unrespo…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for FreeO2 automated oxygen therapy device over startup failure risk
Health Canada published a safety alert on October 8, 2026 for the FreeO2 HW 2.3 automated oxygen therapy device, affecting adult and pediatric patients. A software defect in package 1.4.2 can trigger error 29515 followin…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recalls Avantage inserter handles and grippers over acetabular shell disengagement failure
Health Canada issued a recall on October 8, 2026 for Avantage inserter handles and grippers used during acetabular shell implantation. The recall addresses a confirmed failure mode in which the gripper does not consisten…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues safety alert for Cardinal Health Presource kits containing potentially affected extension tubing components
Health Canada published a safety alert on October 8, 2026 for Cardinal Health Presource kits found to contain a component covered by a prior Welmed extension tubing set advisory. Customers must inspect affected lots befo…
Read the full Health Canada Drugs & Medical Devices brief →Henry Schein recalls Camark SA-manufactured Perma-Sharp sutures distributed outside authorized markets including the United States and Canada
Henry Schein Inc. has determined that Perma-Sharp sutures manufactured by Camark SA, authorized only for the EU, UK, Switzerland, and Israel, were incorrectly distributed in the United States, Canada, Cayman Islands, and…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recall covers fluoroplastic vent tubes released without sterilization across lot 0231048280
Health Canada issued a recall alert on October 6, 2026 for fluoroplastic vent tube devices in lot 0231048280, distributed to customers without undergoing sterilization. The devices do not meet the required sterility assu…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada recalls specific Medline Bariatric Rollator lots over wheel assembly separation and fall-injury risk
Health Canada recalled specific lots of the Medline Bariatric Rollator (SKU: MDS86800XWS) on October 6, 2026, citing disconnection of the front fork stem bolt and wheel assembly from the frame. Affected customers are dir…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada flags FreeO2 automated oxygen therapy device defect requiring hardware correction before return to service
Health Canada published a safety alert on October 6, 2026 for FreeO2 HW 1.2 automated oxygen therapy devices. A battery reading error emerges following a software upgrade from version 1.2.X to 1.4.X, and affected devices…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada safety alert flags Embletta MPR PG memory fault risking patient data integrity and diagnostic failure
Health Canada issued a safety alert on October 6, 2026 for the Natus Embletta MPR PG sleep diagnostic device, citing an internal memory formatting defect. The defect can corrupt patient study data, prevent recording init…
Read the full Health Canada Drugs & Medical Devices brief →Health Canada issues Type II recall of PMS-Carvedilol 25 mg Tablets over N-nitroso-carvedilol impurity in 20 lots
Health Canada published recall RA-82725 on October 6, 2026, covering 20 lots of PMS-Carvedilol 25 mg Tablets distributed nationally by Pharmascience Inc. The affected lots may contain N-nitroso-carvedilol, a nitrosamine …
Read the full Health Canada Drugs & Medical Devices brief →
Get every Health Canada Drugs & Medical Devices brief delivered the day it lands
From $149/month
Cresthaven Analytics monitors Health Canada continuously, applying institutional materiality scoring to every release. Subscribers receive structured briefs via email, portal, and (Professional tier and above) real-time alerts.
View all tiers →