Class IIOngoingZ-1736-2025
Galt Medical Corporation recalls Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introd…
Due to a potential open seal in the sterile barrier packaging.
Galt Medical Corporati…TXMay 14, 2025
Recalls: Process control
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 637–648 of 816 recalls
Class IIOngoingZ-1735-2025
Galt Medical Corporation recalls Introducer Kit- Coaxial Dilator REF: KIT-002-28
Due to a potential open seal in the sterile barrier packaging.
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1734-2025
Galt Medical Corporation recalls GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous proce…
Due to a potential open seal in the sterile barrier packaging.
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1733-2025
Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model N…
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1732-2025
Galt Medical Corporation recalls B Braun Interventional Coaxial Dilator REF: KIT-018-47
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1731-2025
Galt Medical Corporation recalls GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is intended for use…
Due to a potential open seal in the sterile barrier packaging .
Galt Medical Corporati…TXMay 14, 2025
Class IIOngoingZ-1723-2025
Ambu Inc. recalls Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set. Model Number: 622002000US
Incorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope incorrectly states 5.0/2.2 while the back label, shipping box and product ins…
Ambu Inc.MDMay 14, 2025
Class IIOngoingZ-1718-2025
SCIENCE & BIO MATERIALS recalls Bio 1 Granules for Filling ¿ 1 mm (2 cm¿)
Vials of implant bone granules may contain less product then specified on labeling.
SCIENCE & BIO MATERIAL…May 14, 2025
Class IOngoingZ-1717-2025
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Craniotomy Kit
Inadequate weld that can potentially cause the product to disassemble.
Integra LifeSciences C…NJMay 14, 2025
Class IOngoingZ-1716-2025
Integra LifeSciences Corp. (NeuroSciences) recalls CODMAN Disposable Perforator
Inadequate weld that can potentially cause the product to disassemble.
Integra LifeSciences C…NJMay 14, 2025
Class IOngoingZ-1680-2025
Bausch & Lomb Surgical, Inc. recalls Intraocular Lens. enVista Envy IOL
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Bausch & Lomb Surgical…FLMay 14, 2025
Class IOngoingZ-1679-2025
Bausch & Lomb Surgical, Inc. recalls Intraocular lens. enVista Monofocal IOL
In response to an increased number of reports of toxic anterior segment syndrome (TASS) in conjunction with implantation of enVista Aspire and enVista Envy IOLs, and certain enVista monofocal lenses in the U.S.
Bausch & Lomb Surgical…FLMay 14, 2025