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 21681–21700 of 38,428 recalls
Recalled Item: 6" Smallbore Ext Set w/6-Port NanoClave Manifold
The Issue: ICU Medical is expanding the scope of their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS LH
The Issue: Several complaints were received for invalid calibration with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius MRI
The Issue: The automatic ventilation may fail if the position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius GS Premium
The Issue: The automatic ventilation may fail if the position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius Tiro
The Issue: The automatic ventilation may fail if the position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fabius Tiro M
The Issue: The automatic ventilation may fail if the position
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/L Taper Hip Prosthesis
The Issue: Certain packages labeled as size 7.5 Extended Offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer M/L Taper Hip Prosthesis
The Issue: Certain packages labeled as size 7.5 Extended Offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Insertion Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximum Barrier Insertion Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximum Barrier Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Maximum Barrier Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Insertion Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PICC Kit
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neonatal PICC Tray
The Issue: friction holes may affect the sterility of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avenir Muller Stem
The Issue: A potential commingle that could result in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Avenir Muller Stem
The Issue: A potential commingle that could result in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Biomet Comprehensive Segmental Revision System (SRS). Orthopedic...
The Issue: During assembly, an SRS Humeral Distal Body implant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SPIFE Alkaline Hemoglobin Kit
The Issue: Lots of gel kits contained a newer revision
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.