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DEXLOCK Achilles Repair Implant Kits, MAKT4520 – there have been multiple complaints o... (2025)

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.

Moderate

FDANov 11, 2025Nationwide

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 (AVID Medical, Inc.) – devices are not suitable for organ tr... (2025)

Devices are not suitable for organ transplant.

Moderate

FDANov 11, 2025Nationwide• AVID Medical, Inc.

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DEXLOCK Achilles Repair Implant Kits, MAKT4520 – there have been multiple complaints o... (2025)

Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 (AVID Medical, Inc.) – devices are not suitable for organ tr... (2025)

ErgoStar CM 45, Model/Catalog Number: MP01845, Airway... (Draeger, Inc.) – multiple complaints were reported in ... (2025)

ErgoStar CM 55, Model/Catalog Number: MP01855, Airwa... (Draeger, Inc.) – multiple complaints were reported in ... (2025)

ErgoStar CM 40 Model/Catalog Number: MP01840 Airway co... (Draeger, Inc.) – multiple complaints were reported in ... (2025)

Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Couplin... (Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany) – the device has been delivered with a ... (2025)

ErgoStar CM 60, Model/Catalog Number: MP01860, Airwa... (Draeger, Inc.) – multiple complaints were reported in ... (2025)

Access 2 Reaction Vessels, individual, disposable, plasti... (Beckman Coulter, Inc.) – it has been determined that certain l... (2025)

Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Ca... – fall hazard (2025)

Bard InLay Optima Size: 6 Fr. x 14 cm, Ureteral Stent Kit... (C.R. Bard Inc) – labeling discrepancy; ureteral stent ... (2025)

MADSEN ACCUSCREEN TEOAE/DPOAE/ABR Probe (P/N 8-69-41100) (PATH Landsberger Str. 65 Germering Germany) – following a component change in the d... (2025)

Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T, (Bard Peripheral Vascular Inc 1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy. Tempe AZ 85281-2438) – laceration hazard (2025)

BD InLay Optima Ureteral Stent Kit Size: 4.7 Fr. x 26 cm,... (C.R. Bard Inc) – labeling discrepancy; ureteral stent ... (2025)

Hemochron Activated Clotting Time Low-Range Test Cuvette,... (Accriva Diagnostics, Inc.) – foreign object (2025)

Xpert MTB/RIF. Model Number: GXMTB/RIF-US-10. (Cepheid) – product testing did not meet expected... (2025)

Brand Name: Diasol Product Name: 100225-10-DEX100, Liqui... (Diasol, Inc) – safety and efficacy of dialysis acid ... (2025)

Cardiosave Hybrid. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

Cardiosave Rescue. Intra-Aortic Balloon Pump system. (Datascope Corp.) – the ifu addendum revises the preventa... (2025)

Iodine Test (Get Tested International) – unapproved distribution (2025)

Organic Acids Profile Test Large (Get Tested International) – unapproved distribution (2025)