Class IOngoingZ-2360-2026
Abiomed, Inc. recalls Automated Impella Controller (AIC)
Potential software error in the Automated Impella Controller ("AIC" ) when used in conjunction with left ventricular Impella devices.
Abiomed, Inc.MAJun 24, 2026
2026 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 721–732 of 2,088 recalls
Class IOngoingZ-2359-2026
Datex-Ohmeda Inc recalls Panda Freestanding Warmer
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in…
Datex-Ohmeda IncWIJun 24, 2026
Class IOngoingZ-2358-2026
Datex-Ohmeda Inc recalls Giraffe Warmer with Integrated Resuscitation System (iRes)
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in…
Datex-Ohmeda IncWIJun 24, 2026
Class IOngoingZ-2357-2026
Datex-Ohmeda Inc recalls Giraffe Stand-alone Infant Resuscitation System
Blender knob shaft can loosen, which can affect the delivered oxygen concentration. The system can deliver an oxygen concentration that does not match the intended concentration set by the user, potentially resulting in…
Datex-Ohmeda IncWIJun 24, 2026
Class IIOngoingZ-2413-2026
Boston Scientific Corporation recalls Orca Single Use Air/Water and Suction Valves
Boston Scientific is initiating a medical device removal of Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.
Boston Scientific Corp…MAJun 17, 2026
Class IIOngoingZ-2410-2026
AVID Medical, Inc. recalls Halyard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
AVID Medical, Inc.VAJun 17, 2026
Class IIOngoingZ-2409-2026
AVID Medical, Inc. recalls Halyard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
AVID Medical, Inc.VAJun 17, 2026
Class IIOngoingZ-2408-2026
AVID Medical, Inc. recalls Halyard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
AVID Medical, Inc.VAJun 17, 2026
Class IIOngoingZ-2407-2026
AVID Medical, Inc. recalls Halyard
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
AVID Medical, Inc.VAJun 17, 2026
Class IIOngoingZ-2406-2026
Elekta, Inc. recalls MOSAIQ Oncology Information System
Software may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
Elekta, Inc.GAJun 17, 2026
Class IIOngoingZ-2405-2026
Abbott Medical recalls Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 soft…
Software malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command to terminate the test.
Abbott MedicalCAJun 17, 2026
Class IIOngoingZ-2404-2026
Boston Scientific Neuromodulation Corporation recalls Boston Scientific Model SC-4318
Sterile anchors my lack sterility assurance.
Boston Scientific Neur…CAJun 17, 2026