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 30121–30140 of 38,428 recalls
Recalled Item: HDL-Cholesterol plus gen.3.
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Uric Acid plus ver.2 In vitro test for the quantitative
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triglycerides/Glycerol Blanked. In vitro test for the quantitative...
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Creatinine Plus. Intended for use on Hitachi/MODULAR systems for the
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXPRESS Dry Seal Chest Drain
The Issue: Chest drains have a missing o-ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lactate. Intended for use on COBAS INTEGRA 800 and 400 plus systems
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oasis Dry Suction Water Seal Chest Drain
The Issue: Chest drains have a missing o-ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LDL-Cholesterol plus gen.2. The Boehringer Mannheim Direct LDL-Cholesterol...
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ocean Water Seal Chest Drain
The Issue: Chest drains have a missing o-ring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cholesterol Gen.2. The cassette COBAS Integra Cholesterol Gen.2 (CHOL2) contains
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LDL-Cholesterol gen.2. The Boehringer Mannheim Direct LDL-Cholesterol test...
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cholesterol CHOD-PAP. In vitro diagnostic reagent system intended for use
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triglycerides GPO. In vitro test for the quantitative determination of
The Issue: drug interference when using the Trinder reaction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Rapidlab 1265 system is a blood gas analyzer used
The Issue: D50 and D51 diagnostic error codes are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Rapidlab 1260 system is a blood gas analyzer used
The Issue: D50 and D51 Diagnostic error codes are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy
The Issue: IMMULITE 2000/2000XPi Italian Cypress (T23L4), Lots 206 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Cardiovascular Procedure Kits
The Issue: The Overpressure Safety Valve is not cleared with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3(TM) 28 MM I.D.
The Issue: The R3 Constrained outer liner locking groove diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3(TM) 22 MM I.D.
The Issue: The R3 Constrained outer liner locking groove diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R3(TM) 22 MM I.D.
The Issue: The R3 Constrained outer liner locking groove diameter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.