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 6181–6200 of 38,428 recalls
Recalled Item: Colonoscope
The Issue: Specific repaired colonovideoscopes were assembled without an adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope
The Issue: Specific repaired colonovideoscopes were assembled without an adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope
The Issue: Specific repaired colonovideoscopes were assembled without an adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Colonoscope
The Issue: Specific repaired colonovideoscopes were assembled without an adhesive
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023
The Issue: The device has a grip detail (right angle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Version 7.2.100
The Issue: Measurements on a Secondary Capture 2D image, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Version 7.1.000
The Issue: Measurements on a Secondary Capture 2D image, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Version 7.2.000
The Issue: Measurements on a Secondary Capture 2D image, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Version 7.1.000US
The Issue: Measurements on a Secondary Capture 2D image, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Version 7.3.000
The Issue: Measurements on a Secondary Capture 2D image, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synapse PACS - Version 7.2.200
The Issue: Measurements on a Secondary Capture 2D image, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife Adult Manual Resuscitator
The Issue: Risk of hypoventilation caused by duckbill and ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.