Class IOngoingZ-1726-2025
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Compressor
A cybersecurity vulnerability was discovered through internal testing.
Baxter Healthcare Corp…ILMay 21, 2025
Class I recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 457–468 of 595 recalls
Class IOngoingZ-1725-2025
Baxter Healthcare Corporation recalls Welch Allyn Life2000 Ventilation system
A cybersecurity vulnerability was discovered through internal testing.
Baxter Healthcare Corp…ILMay 21, 2025
Class IOngoingZ-1698-2025
Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Nu…
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Vyaire MedicalILMay 21, 2025
Class IOngoingZ-1697-2025
Vyaire Medical recalls Brand Name: AirLife Product Name: AirLife Infant Heated Wire Circuit Model/Catalog Nu…
Adapters may disconnect during setup or while in use, potentially interrupting ventilation. Any disconnection can result in severe consequences for neonates, including hypoxia, hypercapnia, and organ failure.
Vyaire MedicalILMay 21, 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-1682-2025
Smiths Medical ASD, Inc. recalls CADD Solis VIP Ambulatory Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Smiths Medical ASD, In…MNMay 14, 2025
Class IOngoingZ-1681-2025
Smiths Medical ASD, Inc. recalls CADD-Solis Infusion Pump Models: 1) PUMP KIT
There is a potential for thermal damage in CADD-Solis and CADD- Solis VIP infusion pumps.
Smiths Medical ASD, In…MNMay 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
Class IOngoingZ-1668-2025
Smiths Medical ASD, Inc. recalls CADD-Solis VIP Ambulatory Infusion Pump
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Smiths Medical ASD, In…MNMay 14, 2025
Class IOngoingZ-1667-2025
Smiths Medical ASD, Inc. recalls CADD-Solis HPCA Ambulatory Infusion Pump
Affected pumps may trigger an erroneous (false) Upstream Occlusion Alarm under certain conditions, which will interrupt an active infusion. Interruption or delay of therapy can lead to serious patient injury or death.
Smiths Medical ASD, In…MNMay 14, 2025