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 1161–1180 of 38,428 recalls
Recalled Item: CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K
The Issue: XXX
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FDR Visionary Suite
The Issue: It was found that the shaft for mounting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Galaxy System Product Name: Galaxy System Model/Catalog Number:
The Issue: Due to Users not having access to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Option"ELITE Vena Cava Filter System UDI-DI code: 00886333217151
The Issue: Due to complaints of increased resistance when advancing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity NT Oxygenator
The Issue: Medtronic identified an Affinity NT Oxygenator unit with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint SPX6
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Millenium MPR
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint Model 4XX
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Shanghai United Imaging Healthcare Co.
The Issue: Third-party outer covers can become trapped between patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Millenium MG/MC
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Millenium Myosight
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Starcam/Camstar
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint Helix
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sopha Medical Vision (SMV) DSXi/DST-XLi
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint SPX4
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elscint Varicam
The Issue: GE HealthCare has become aware that certain Nuclear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.