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 20041–20060 of 38,428 recalls
Recalled Item: Vanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment
The Issue: The implant only has one bolt in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iView DAB Detection Kit w/o Secondary Antibody
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INFORM HPV III Fam 16 Probe - US Export
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENTANA anti-Helicobacter Pylori (SP48) PAB 250
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iView DAB Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ANTI-PAN Keratin Primary Antibody
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENTANA ISH iView Blue Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEXES VEN IVIEW DAB DET KT JPN-US EXPORT
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CINtec Histology (250)
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISH Protease 3
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONFIRM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ultraView SISH DNP Detection Kit US
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OptiView Amplification Kit (250 test)
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ultraView Universal Alkaline Phosphatase Red Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENTANA Basal Cell Cktl
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ultraView Universal DAB Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ultraView SISH DNP Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CONFIRM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ISH iVIEW Blue Plus Detection Kit
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CINtec p16 Histology (250) CE
The Issue: Leaking and sticking reagent dispensers for horseradish peroxidase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.