Class IIOngoingZ-1127-2026
Merit Medical Systems, Inc. recalls Merit Medical
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class II recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,321–1,332 of 3,866 recalls
Class IIOngoingZ-1126-2026
Merit Medical Systems, Inc. recalls Merit Medical
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1125-2026
Merit Medical Systems, Inc. recalls Merit Medical
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1124-2026
Merit Medical Systems, Inc. recalls Allwell Inflation Device
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1123-2026
Merit Medical Systems, Inc. recalls Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN…
Inflation device handle may detach from the syringe during procedure.
Merit Medical Systems,…UTJan 28, 2026
Class IIOngoingZ-1122-2026
Mazor Robotics Ltd recalls Mazor X robotic guidance system REF: TPL0059
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
Mazor Robotics LtdJan 28, 2026
Class IIOngoingZ-1121-2026
Baxter Healthcare Corporation recalls SIGMA Spectrum Infusion Pump
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the defective grease may lead to the device having insufficient lubrication on…
Baxter Healthcare Corp…ILJan 28, 2026
Class IIOngoingZ-1120-2026
ICU Medical, Inc. recalls ICU Medical Plum Solo Precision IV Pump
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy.…
ICU Medical, Inc.ILJan 28, 2026
Class IIOngoingZ-1119-2026
ICU Medical, Inc. recalls ICU Medical Plum Duo Precision IV Pump
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy.…
ICU Medical, Inc.ILJan 28, 2026
Class IIOngoingZ-1118-2026
ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy.…
ICU Medical, Inc.ILJan 28, 2026
Class IIOngoingZ-1113-2026
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. recalls Philips Azurion system
Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect image content and/or loss of data.…
PHILIPS MEDICAL SYSTEM…Jan 28, 2026
Class IIOngoingZ-1112-2026
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING recalls GE Healthcare Omni Legend
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images.…
GE MEDICAL SYSTEMS ISR…Jan 28, 2026