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 10481–10500 of 38,428 recalls
Recalled Item: METREX RESEARCH CORP SPONGE
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. BECTON DICKINSON BD Vacutainer C&S Preservative Urine Tube TUBE
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DYNAREX Dynarex SWABSTICK
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: B. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cadwell Disposable Ground Electrodes Grounding Pad 1.25 X 1.75 Inch Dimensions
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Strep test: a. McKesson Medical-Surgical McKesson Rapid Test Kit McKesson
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultracell Eye Pledget Ultracell 2 X 6 X 1 mm
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. McKesson Rapid Test Kit McKesson Consult Fertility Test hCG
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palmero Healthcare
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alere Toxicology TABLET
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. McKesson DISINFECTANT
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dynarex¿ PAD
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MERIT MEDICAL SYSTEMS Temno Soft Tissue Biopsy Device Temno 14
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COOPER SURGICAL Milex PESSARY
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mckesson GYNECATH H/S CATHETER 5FR (10/CS) Model Number: 11-19610
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE INDUSTRIES Medline Catheter Insertion Tray Medline Foley Without...
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fischer Cone Biopsy Excisor EXCISOR
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M COMPANY 3M PAD
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MORRISON MEDICAL Morrison Medical OB KIT
The Issue: Facility Temperature excursions (from June 2021-August 2021) prior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.