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FDA Recalls
›Device Recalls

FDA Device Recalls

Recalls of medical devices, diagnostic equipment, implants, and surgical instruments.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 1681–1700 of 39,430 recalls

Class IIOngoing

Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.

AVID Medical, Inc.

Devices are not suitable for organ transplant.

November 11, 2025 · DeviceView details →

Ongoing

Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.

AVID Medical, Inc.

Devices are not suitable for organ transplant.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for urologic applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

DEXLOCK Achilles Repair Implant Kits, MAKT4520

Medline Industries, LP

There have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit and drill guide may prolong the surgical procedure.

November 11, 2025 · DeviceView details →

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08

AVID Medical, Inc.

Devices are not suitable for organ transplant.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatment in urological applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological and gynecological applications.

Olympus Corporation of the Americas

Complaints of the ceramic tip of the resection sheath breaking have been received.

November 11, 2025 · DeviceView details →

Class IIOngoing

COULTER DxH Diluent, REF 628017 COULTER DxH ECO Diluent REF C67250 For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells on all UniCel DxH Coulter Cellular Analysis Systems. For use as a rinsing agent on the UniCel DxH Slidemaker Stainers. For use as a diluent in conjunction with DxH ECO Cell Lyse for counting and sizing blood cells. For use as a rinsing agent.

Beckman Coulter, Inc.

Due to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers.

November 10, 2025 · DeviceView details →

ErgoStar CM 60, Model/Catalog Number: MP01860, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Draeger, Inc.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

November 10, 2025 · DeviceView details →

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Draeger, Inc.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

November 10, 2025 · DeviceView details →

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Draeger, Inc.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

November 10, 2025 · DeviceView details →

Class IIOngoing

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.

Waldemar Link GmbH & Co. KG (Mfg Site)

The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.

November 10, 2025 · DeviceView details →

ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for conduction of respiratory gases between the breathing system and the patient interface. (e.g. endotracheal tube mask) of a mechanically ventilated patient.

Draeger, Inc.

Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts.

November 10, 2025 · DeviceView details →

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