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 2081–2100 of 38,428 recalls
Recalled Item: EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is
The Issue: Due to a software bug the robotic arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IontoPatch 80
The Issue: The nonwoven pads in the device do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IontoPatch STAT
The Issue: The nonwoven pads in the device do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Cardiology Hemodynamics Software
The Issue: Due to complaints, software update may cause software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Change Healthcare Cardiology Hemo Software
The Issue: Due to complaints, software update may cause software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extended Tip Applicator
The Issue: Devices contain potentially out-of-specification levels of endotoxins and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extended Tip Applicator
The Issue: Devices contain potentially out-of-specification levels of endotoxins and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog...
The Issue: The Instructions for Use do not match the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product: Atellica CH Diluent - CONS 2 x 1.5L
The Issue: Contamination of the diluent by sodium hypochlorite (NaOCl)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extended Tip Applicator 8CM
The Issue: Devices contain potentially out-of-specification levels of endotoxins and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Nail
The Issue: Investigation determined that one lot of the T2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Femoral Nail
The Issue: Investigation determined that one lot of the T2
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insyte Autoguard Shielded IV Catheter
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insyte Autoguard Winged Shielded IV Catheter
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Insyte Autoguard Shielded IV Catheter
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: Due to customer complaints, there is the possibility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.