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 6941–6960 of 38,428 recalls
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Curaplex manual resuscitators with integrated manometer
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariSoft infusion set
The Issue: The Varisoft infusion set is used in conjunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Alaris Pump infusion sets (Product Name
The Issue: Affected infusion sets labeled as free of DEHP
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariSoft infusion set
The Issue: The Varisoft infusion set is used in conjunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ventlab
The Issue: A backwards leak present in the integrated manometer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xstar Kojo Safety Slit Knife
The Issue: One lot of Part Number 373025, Xstar¿ Kojo
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 3400 Chemistry System Product Code 6844458 Running Software
The Issue: During planned monitoring of data post-release of Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 4600 Chemistry System Product Code 6802445 and Product
The Issue: During planned monitoring of data post-release of Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System Product Code 6844461 Running Software
The Issue: During planned monitoring of data post-release of Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System Product Code 6802413 and Product
The Issue: During planned monitoring of data post-release of Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System Product Code 6802783 and Product
The Issue: During planned monitoring of data post-release of Software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stay Safe Cap
The Issue: Updating the labeling to include additional warnings and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Impella Controller (AIC)
The Issue: Pump not detected as connected to controller due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARDIOHELP Emergency Drive
The Issue: Product removal due to possible blocking or impairment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Automated Impella Controller (AIC)
The Issue: Pump not detected as connected to controller due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Spectral CT on Rails
The Issue: This recall is part of a 2-issue recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compress Device Short Anchor Plug
The Issue: Anchor plugs potentially have metal burrs in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compress Device Short Anchor Plug
The Issue: Anchor plugs potentially have metal burrs in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Compress Device Short Anchor Plug
The Issue: Anchor plugs potentially have metal burrs in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.