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 6861–6880 of 38,428 recalls
Recalled Item: Injection Needle
The Issue: The efficacy of the manual cleaning process cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Injection Needle
The Issue: The efficacy of the manual cleaning process cannot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker Sage PrimaFit External Urine Management System for the Female Anatomy
The Issue: A small percentage of devices in three lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartPath to dStream for 1.5T
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenia 1.5T CX
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Initial System
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Achieva 1.5T Conversion
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T Power/Pulsar
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intera 1.5T
The Issue: component failure in the Gradient Coil could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Leg bag
The Issue: Undeclared Latex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Leg bag
The Issue: Undeclared Latex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity i Processing Module The Alinity i Processing
The Issue: The devices contain a dry natural rubber (latex)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity c Processing Module The Alinity c Processing
The Issue: The devices contain a dry natural rubber (latex)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c4000 Processing Module 02P24-02 02P24-40 01R24-56 01R25-56
The Issue: The devices contain a dry natural rubber (latex)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: epoc NXS Host Blood Analysis System
The Issue: Siemens Healthcare Diagnostics Inc. has confirmed a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott CELL-DYN Ruby
The Issue: The devices contain a dry natural rubber (latex)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Leg bag
The Issue: Undeclared Latex
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health Clean Stool Transportation System-For the collection
The Issue: Due to a manufacturing defect, certain Para-Pak vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Para-Pak Zn-PVA/10% Formalin-for the routine collection
The Issue: Plastic vials contain a manufacturing defect may cause
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.