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 33681–33700 of 38,428 recalls
Recalled Item: Fassier-Duval IM Telescopic System. Orthopedic intramedullary rod implant....
The Issue: The outer package label contained the incorrect length
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Vertix MD Trauma systems radiographic X-ray
The Issue: There is a potential issue and possible hazard
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CRBM Slides
The Issue: The firm identified a potential for biased carbamazepine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FAS-LOC 6 Foot Disposable Extension Cable with Safe Connect/Screw Down.
The Issue: Remington Medical discovered an error on the FL-601-97
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Oxylog 3000 plus ventilators
The Issue: The potentiometers (knobs) for setting the ventilation parameters
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zoll Medical X Series
The Issue: Defibrillator/Pacemaker/Monitor May Latch in a Continuous Device Reset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEVION S250
The Issue: Geometric positioning error can occur after a rotational
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDDP Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Barbiturate Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ketamine Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxycodone Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tramadol Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Salmonella typhi Antigen Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amphetamine Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malaria pf Antigen Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Propoxyphene Test Strip
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malaria pf Antigen Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Malaria pf/pan Antigen Test Card
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: H. Pylori Ab Test Card-Serum
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dengue IgG/IgM
The Issue: Products shipped to US locations that do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.