Class IIOngoingZ-2520-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HM 11V Li-ion Backup Battery
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 133–144 of 3,846 recalls
Class IIOngoingZ-2519-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3" System Controller Model/Catalog Numb…
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2518-2026
Thoratec LLC recalls Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits M…
Due to 11 volt Backup Battery failures.
Thoratec LLCCAJun 24, 2026
Class IIOngoingZ-2517-2026
Merit Medical Systems, Inc. recalls Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 0…
Due to unsealed portions of pouches.
Merit Medical Systems,…UTJun 24, 2026
Class IIOngoingZ-2516-2026
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer.…
Inspire Medical System…MNJun 24, 2026
Class IIOngoingZ-2515-2026
Inspire Medical Systems Inc. recalls Brand Name: Inspire Medical Systems
Products are labeled with incorrect Use By Date, extending beyond the validated three-year shelf life from date of manufacturer.…
Inspire Medical System…MNJun 24, 2026
Class IIOngoingZ-2514-2026
BD SWITZERLAND SARL recalls BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" S…
Due to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than tightening securely.…
BD SWITZERLAND SARLJun 24, 2026
Class IIOngoingZ-2513-2026
Beta Bionics, Inc. recalls iLet Bionic Pancreas
The reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure could occur when the user successfully slides the unlock slider on the Lock…
Beta Bionics, Inc.CAJun 24, 2026
Class IIOngoingZ-2509-2026
Staar Surgical AG recalls Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product D…
Due to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses.
Staar Surgical AGJun 24, 2026
Class IIOngoingZ-2508-2026
Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) CRANI
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter c…
Medline Industries, LPILJun 24, 2026
Class IIOngoingZ-2507-2026
Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: 1) RETINA LAC/USC CDS
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter c…
Medline Industries, LPILJun 24, 2026
Class IIOngoingZ-2506-2026
Medline Industries, LP recalls MEDLINE Medical Procedure Kits labeled as: KIT URO ROBOT CYSTECTOMY
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter c…
Medline Industries, LPILJun 24, 2026