Class IIOngoingZ-0993-2026
Cook Incorporated recalls Flexor Check-Flo Introducers and Sets
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification.…
Cook IncorporatedINDec 31, 2025
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 277–288 of 816 recalls
Class IIIOngoingZ-0938-2026
Instrumentation Laboratory recalls HemosIL SynthAFax. Partial Thromboplastin Time Tests.
Recalled lots were manufactured with double the amount of preservative concentration.
Instrumentation Labora…MADec 24, 2025
Class IIOngoingZ-0925-2026
Zimmer Surgical Inc recalls Zimmer Dermatome AN
The devices may have a misaligned thickness control bar.
Zimmer Surgical IncOHDec 24, 2025
Class IIOngoingZ-0924-2026
Zimmer Surgical Inc recalls Zimmer Air Dermatome
The devices may have a misaligned thickness control bar.
Zimmer Surgical IncOHDec 24, 2025
Class IIOngoingZ-0910-2026
Steris Corporation recalls AMSCO 7053HP Washer/Disinfector Model/Catalog Number: 7053HP Product Description:…
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Steris CorporationOHDec 17, 2025
Class IIOngoingZ-0909-2026
Steris Corporation recalls AMSCO 7052HP Washer/Disinfector Model/Catalog Number: 7052HP Product Description:…
Wire connected to the electrical box may shift out of its intended position, which may result in electrical arcing. Electrical arcing remains internal within the unit (no risk of shock to users).
Steris CorporationOHDec 17, 2025
Class IIOngoingZ-0890-2026
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Endo Model Knee Fusion Nail SK
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.
Waldemar Link GmbH & C…Dec 17, 2025
Class IIOngoingZ-0887-2026
Bard Peripheral Vascular Inc recalls Safe-T-Centesis 6 Fr Catheter Drainage Tray
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt pos…
Bard Peripheral Vascul…AZDec 17, 2025
Class IIOngoingZ-0847-2026
Baxter Healthcare Corporation recalls Welch Allyn INF BAG
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
Baxter Healthcare Corp…ILDec 10, 2025
Class IOngoingZ-0586-2026
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IIOngoingZ-0718-2026
B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administratio…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025
Class IIOngoingZ-0717-2026
B Braun Medical Inc recalls IV Administration Set utilized in gravity IV administration sets and pump administratio…
Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
B Braun Medical IncPADec 3, 2025