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 22021–22040 of 38,428 recalls
Recalled Item: Intellivue iX Information Center Software - All PIIC iX Surveillance
The Issue: Once a surveillance station is restarted on January
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Custom Perfusion Systems
The Issue: Medtronic custom perfusion tubing packs contain Terumo OPS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi BR-MA (CA15-3)
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ /IMMULITE 1000 ¿ Gastrin
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ /IMMULITE ¿ 1000 BR-MA (CA15-3)
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ /IMMULITE ¿ 1000 OM-MA (CA125)
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ DHEA-SO4
The Issue: The concentrations for biotin listed in the non-interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Anti HBc
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Gastrin
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension¿ Free Thyroxine (FT4L) Flex¿ reagent cartridge
The Issue: The concentrations for biotin listed in the non-interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Mass Creatine Kinase (MMB) Flex¿ reagent cartridge
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ HBc IgM
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ /IMMULITE ¿ 1000 CEA
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi CEA
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension¿ Sirolimus (SIRO) Flex¿ reagent cartridge
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista¿ Thyroid Stimulating Hormone (TSH) Flex¿ reagent cartridge
The Issue: The concentrations for biotin listed in the non-interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi Folic Acid
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur¿ Cyclosporine
The Issue: The concentrations for biotin listed in the non-interfering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ /IMMULITE ¿ 1000 Vitamin B12
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE ¿ 2000/IMMULITE ¿ 2000 XPi 3g Allergy specific IgE Universal Kit
The Issue: Concentrations for the level of biotin that does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.