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 20981–21000 of 38,428 recalls
Recalled Item: Bio-Stable 5F DL-55CM IR-145 Kit Non-Valved with Nitinol GW PG
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS 5F DL XPP KIT
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F SL-55CM MST-70 Kit Valved with Nitinol Guidewire PG
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAN 5F DL BIOFLO PASV PICC NURSING TRAY
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS 5F DL BIOFLO PASV
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS 5F DL XCELA PICC
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit PG
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TANDEM 5F DL BIOFLO PASV
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F SL-55CM IR-145 Kit Non-Valved with Nitinol GW PG
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS TANDEM 5F DL BIOFLO PASV
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC (Valved) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS 5F DL XPP
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bio-Stable 5F DL-55CM MST-70 KIT Non-Valved with Nitinol Guidewire PG
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC (NV) 5FDL-55cm Maximal Barrier Nursing Kit w/70cm Nitinol Wire PG
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS TANDEM 5F DL BIOFLO PICC
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS 5F DL BIOFLO PASV
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microintroducer Kit
The Issue: A component of the kits might contain unsafe
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiMedica Catalys Precision Laser System
The Issue: Software upgrade exhibits failures when executing Daily Alignment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS-7
The Issue: Panasonic has issued a Mandatory Product Safety Notice,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products PHYT Slides
The Issue: There is a potential for imprecise results when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.