Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 7721–7740 of 38,428 recalls
Recalled Item: BD Synapsys Informatics Solution
The Issue: There is a risk of mis-association of patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BeamAdjust software Version 2.3.3 The following devices are
The Issue: Generated calibration file will not be correct in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FRED Flow Re-Direction Endoluminal Device
The Issue: Intracranial aneurysm flow diverter device may be manufactured
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vios Monitoring System Bedside Monitor
The Issue: A premature failure condition was identified with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Giraffe Incubator Carestation CS1
The Issue: Prior to current established manufacturing practices, higher levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Giraffe Omnibed Carestation CS1
The Issue: Prior to current established manufacturing practices, higher levels
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NanoZoomer S360MD Slide scanner system-automated system for creating
The Issue: If the wrong barcode information is recorded in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System Implant Kit
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Catalyft LS Expandable Interbody System
The Issue: There is the potential for out of specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy...
The Issue: 1. Wheels loosening over time with use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vanta with AdaptiveStim Implantable Neurostimulator
The Issue: A cardioversion procedure may damage the electronics in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
The Issue: Reagent packs could potentially contain incorrect wells, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Troponin I ES Calibrators
The Issue: Reagent packs could potentially contain incorrect wells, which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: IABP may lose the ability to charge batteries
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cios Select VA 21 with FD- A Mobile X-ray system
The Issue: Incorrect glue was applied on the plexiglass sheet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.