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 14461–14480 of 38,428 recalls
Recalled Item: Flexible Intubation Fiberscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible DCI Intubation Fiberscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 40cc IAB (Japan) -
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 35cc IAB...
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 8Fr 50cc IAB Kit P/N:
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Intubation Fiberscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 8Fr 50cc IAB Kit
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Linear 7.5Fr 25cc IAB Kit P/N:
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Intubation Fiberscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 35cc IAB...
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-MEGA 7.5Fr 30cc IAB
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 40cc IAB...
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Intubation Video Endoscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Trans-Ray 7Fr 34cc IAB...
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Balloon Catheters (IABs)-MEGA 7.5Fr 40cc IAB Kit P/N:
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-YAMATO PLUS-R 7.5Fr 30cc IAB...
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation Plus 7.5 Fr 40cc IAB
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-TRANS-RAY PLUS 7.5Fr 40cc IAB...
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Datascope Intra-Aortic Ballon Catheters (IABs)-Sensation 7Fr 40cc IAB Kit P/N:
The Issue: Endotoxin Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flexible Intubation Video Endoscope
The Issue: Updated sterilization instructions are being provided to ensure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.