Class IIOngoingZ-1737-2025
Galt Medical Corporation recalls Introducer Kit- Tearaway MicroSlide REF KIT-051-01
Due to a potential open seal in the sterile barrier packaging.
Galt Medical Corporati…TXMay 14, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,885–1,896 of 2,908 recalls
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
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-1729-2025
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor
Patient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required messages,2)Monitor may freeze and reboot at start of 12-lead ECG or after, 3)May reboot…
Remote Diagnostic Tech…May 14, 2025
Class IIOngoingZ-1728-2025
Inari Medical - Oak Canyon recalls Artix MT Thrombectomy Device
Thrombectomy device specifies vessel range of 2.5-6 mm on the pouch, carton, and Instructions for Use rather than the correct vessel range of 3-6 mm, which could incrementally increase the radial force on the artery, whi…
Inari Medical - Oak Ca…CAMay 14, 2025
Class IIOngoingZ-1724-2025
Integra LifeSciences Corp. (NeuroSciences) recalls INSPIRA AIR BALLOON DILATION SYSTEM 10x40
Incorrect product packaged in INSPIRA AIR Balloon Dilation System carton.
Integra LifeSciences C…NJMay 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-1722-2025
Philips North America LLC recalls Microstream Advance Neonatal-Infant Intubated CO2 Filter Line marketed as Adt/Pedi Intu…
Disconnection of the adapter from the endotracheal tube can potentially be difficult or not possible.
Philips North America…MAMay 14, 2025