Regulatory Updates
Sep 10, 2026•1 min read
Stryker Issues Labeling Alert for T2 Alpha IMN Advanced Locking Screw Lot
Stryker reports a labeling error in one lot of T2 Alpha IMN advanced locking screws, which contain 75 mm screws instead of the specified 57.5 mm.
Regulatory Updates
Sep 9, 2026•1 min read
Philips Unity & BV Pulsera C‑Arm Systems May Experience X‑ray Failure Due to Air Bubbles in Monoblock Oil
Air bubbles in the monoblock oil of Philips Unity and BV Pulsera C‑arm units can cause flashovers, preventing X‑ray generation during early use after long storage.
Regulatory Updates
Sep 9, 2026•1 min read
MHRA Issues Multiple Field Safety Notices (31 Aug – 4 Sep 2026)
MHRA published a series of Field Safety Notices covering devices such as Acu‑Loc 2, bedside monitors, orthopaedic cements and a peripheral artery stent‑graft between 31 Aug and 4 Sep 2026.
Regulatory Updates
Sep 4, 2026•1 min read
Health Canada Alert: Stryker LifePak R35 Connector Seating Issue
Health Canada warns that certain printer and modem access port connectors on Stryker LifePak R35 monitor‑defibrillators may not be fully seated during production.
Regulatory Updates
Sep 4, 2026•1 min read
Stryker LifePak R-35 Monitor-Defibrillator May Have Improperly Seated Connectors
Stryker discovered that some LifePak R-35 units may have printer and modem access port connectors not fully seated, potentially appearing flush or recessed.
Regulatory Updates
Sep 4, 2026•1 min read
Boston Scientific Initiates Recall of Imager II Angiographic Catheters Over Tip Issue
Boston Scientific is recalling Imager II Angiographic Catheters after discovering reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.
Regulatory Updates
Sep 4, 2026•1 min read
Boston Scientific Initiates Recall of Imager II Angiographic Catheters
Boston Scientific is recalling Imager II catheters due to reduced stabilizing agents in the tip, which may increase risk of tip degradation and detachment.
Regulatory Updates
Sep 4, 2026•1 min read
Gore VIABAHN® Device Quality Issue Identified
Gore discovered some VIABAHN® devices were processed on equipment outside validated range, risking incorrect distal tip bonding.
Regulatory Updates
Sep 3, 2026•1 min read
MHRA publishes field safety notices for medical devices (24‑28 Aug 2026)
The UK Medicines and Healthcare products Regulatory Agency listed several field safety notices for devices such as femoral head adapters, infusion pump cassettes and fluoroscopic X‑ray systems between 24‑28 August 2026.
Regulatory Updates
Sep 3, 2026•1 min read
Balt Extrusion Recalls ANRYV Connectors Over Endotoxin Test Issue
Balt Extrusion is voluntarily recalling certain ANRYV connector lots after bacterial endotoxin test failures; no patient harm reported.
Regulatory Updates
Sep 3, 2026•1 min read
Balt Extrusion Voluntarily Recalls ANRYV Connectors Over Bacterial Endotoxin Test Failure
Balt Extrusion is voluntarily recalling specific ANRYV connector lots after non‑conforming bacterial endotoxin test results, affecting standalone connectors and those in selected kits; no patient harm reported.
Regulatory Updates
Sep 3, 2026•1 min read
MFDS to Hold Public-Private Forum on Digital Convergence Medicines Regulation
The MFDS will host a public‑private meeting on the 15th in Seoul to discuss regulatory and review processes for digital convergence medicines under the Digital Medical Device Act.
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