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 11601–11620 of 38,428 recalls
Recalled Item: SIMPLEXA COVID-19 Positive Control Pack
The Issue: Due to unapproved raw materials used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation/RayPlan versions 4 - 11A
The Issue: An issue where the combined density in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS TOXO IgG Avidity (TXGA)
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS SARS-COV-2 IgM
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS RUB IgG (RBG)
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS FSH
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Estradiol II
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Lyme IgG II (LYM)
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS PRG Progesterone
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS LH
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Measles IgG (MSG)
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Clostridium Difficile GDH
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS DEX@
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Lyme IgM II (LYM)
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS B.R.A.H.M.S. PROCALCITONIN PCT
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Mumps IgG (MPG)
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS SARS-COV-2 IgG
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VIDAS Clostridium Difficile Toxin A&B
The Issue: bioMerieux has been receiving an increasing number of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci SP Surgical systems with the following Model Name/
The Issue: Issue was identified during internal engineering evaluation. Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CombiDiagnost R90 is multi-functional general R/F systems.
The Issue: The Aleva monitor requires certain labels to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.