규제 업데이트

Health Canada alerts that a Stryker T2 Alpha IMN advanced locking screw lot is mislabeled, containing 75 mm screws rather than the specified 57.5 mm.

Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.

Boston Scientific is recalling Imager II catheters due to reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.

Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.

Health Canada has issued a retail recall of JAMP Temozolomide 140 mg capsules (lot RLTS0225A) because the active ingredient temozolomide is out of specification.

Health Canada alerts that Carestation 850 and 850C anesthesia systems may shut down unexpectedly if AC mains power is disconnected or lost.

The UDI label for model p7924a13 incorrectly lists a 40‑inch surface, while the approved configuration is a 36‑inch surface, risking incompatibility with bed frames.

Starting April 5 2026, Health Canada observed elevated KPC unexpected‑positive rates in final QC testing of BIOFIRE® FILMARRAY® Pneumonia, Pneumonia Plus and Joint Infection panels, linked to nucleic‑acid contamination in the pouch.

Health Canada reports failures in sterile barrier integrity testing for Maquet percutaneous insertion kits, limiting the FSCA to all PIK line products within shelf‑life.

Health Canada identified sterile barrier integrity failures in Maquet's percutaneous insertion kit and dilator sets, affecting all PIK line products within shelf-life.

Health Canada has issued a recall of Twins Herbal’s Idakole and Pelorie liquid products, which were sold without market authorization and contain the undeclared prescription drug sildenafil. Consumers should stop use and contact a healthcare provider.

Customer complaints revealed lamina fluid leaks in Beckman Coulter iQ200 and DxU 840m/850m analyzers due to a compromised rinse‑line check valve.