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 481–500 of 38,428 recalls
Recalled Item: FreeStyle Libre 3 Plus Sensor UDI-DI code: 00357599819002
The Issue: Due to a manufacturing process issue that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeShield Drug Library Management (DLM)
The Issue: For certain customers, the Change Summary review option
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Vapor 2000. Unheated
The Issue: A certain component of affected devices was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeShield Drug Library Management (DLM)
The Issue: Software issue only allows Concentration Limits to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Laboratories
The Issue: Ophthalmic procedure packs may have incomplete seals affecting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Vapor 3000. Unheated
The Issue: A certain component of affected devices was not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BIOSURE HA SCREW
The Issue: Removal of affected lot of screws due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Air Dermatome
The Issue: The devices may have a misaligned thickness control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Dermatome AN
The Issue: The devices may have a misaligned thickness control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S. Typhi/Para Typhi A Antigen
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Male Fertility Sperm Test for Home Use (Cassette)
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Exploro Highly Sensitive Male Fertility / Sperm Concentration Test
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivoo Protein Test
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LotFancy Urinary Tract Infection Urine (UTI) Test Strips
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivoo Vaginal pH Test
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivoo pH Test
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vivoo Sodium Test
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LH One Step Ovulation Test Device (Urine)
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Menopause Test Cassette (Urine)
The Issue: Test strips and other tests including for near-patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.