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 4141–4160 of 38,428 recalls
Recalled Item: Biodesign Fistula Plug C-FPS-0.4-2 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cysto
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPB-0.4 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Essentia MAJ Laparotomy Std Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Day Surgery General Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPS-0.2-2 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Recto-Vaginal Fistula Plug RVP-0.4 - For implantation to reinforce
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ENT
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPS-0.7 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthroscopy Pack
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Open Shoulder
The Issue: ACS identified that due to an inoperable chart
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biodesign Fistula Plug C-FPS-0.4 - For implantation to reinforce soft
The Issue: Products expire prior to the expiration date printed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FILMARRAY 2.0 INSTRUMENT
The Issue: Salmonella Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infusomat Space Infusion System/ Large Volume Pump
The Issue: Extension of previous recall RES 92978. Pumps have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FILMARRAY TORCH MODULE BOX
The Issue: Salmonella Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: General Purpose Syringe McKesson 60 mL Luer Lock Tip Without Safety
The Issue: The syringes that were inadvertently shipped from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Azurion 7M20 systems with FlexArm ceiling-mounted system
The Issue: The motorized longitudinal movement of the FlexArm stand
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The EPIONE device v1.0.2 is a user controlled
The Issue: Quantum Surgical has become aware that a component
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Centricty PACS
The Issue: GE HealthCare has become aware of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.