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FDA’s QMSR Inspection Update Signals New Compliance Standards for U.S. Surgical Device Suppliers

FDA’s QMSR Inspection Update Signals New Compliance Standards for U.S. Surgical Device Suppliers

A stronger non-recall story from the April 14–20 window is the FDA’s April 14, 2026 posting of materials from its town hall on Quality Management Syst...

By Alexander Reid
FDA Class I Recall: Stryker TMJ Implant Correction Raises Skull Penetration Risk Concerns

FDA Class I Recall: Stryker TMJ Implant Correction Raises Skull Penetration Risk Concerns

WASHINGTON, April 20, 2026 — The U.S. Food and Drug Administration has classified Stryker’s correction involving certain patient-fitted temporomandibu...

By Elara Whitestone
FDA Class I Recall: Medline Angiographic Syringes Raise Safety and Supply Chain Concerns in U.S. Procedure Rooms

FDA Class I Recall: Medline Angiographic Syringes Raise Safety and Supply Chain Concerns in U.S. Procedure Rooms

A Class I recall involving Medline’s Namic Angiographic Rotating Adaptor Control Syringes is drawing attention across the U.S. surgical and interventi...

By Ava Renshaw
FDA Early Alert on Cook Medical Sizing Catheters Raises Risk of Device Breakage in Vascular Procedures

FDA Early Alert on Cook Medical Sizing Catheters Raises Risk of Device Breakage in Vascular Procedures

The FDA’s April 9, 2026 early alert on certain Cook Medical sizing catheters is not yet a confirmed recall, but it is already significant news for the...

By Emily Carson

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