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 8601–8620 of 38,428 recalls
Recalled Item: VITROS 5600 Integrated System- For use in the in vitro quantitative
The Issue: MicroTip Pack Opener Assembly Potentially Not Removing or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT 7600 Integrated System - For use in the in vitro quantitative
The Issue: MicroTip Pack Opener Assembly Potentially Not Removing or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System - . For use in
The Issue: MicroTip Pack Opener Assembly Potentially Not Removing or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Storage and Retrieval Module (SRM)-Laboratory Automation system Brand names of
The Issue: Firmware versions have the potential to mis-associate sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Input Output Module (IOM) FLX-201-Laboratory Automation system Brand names of
The Issue: Firmware versions have the potential to mis-associate sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vesmatic Cube 80 Interface Module (VMC)-Laboratory Automation system Brand names
The Issue: Firmware versions have the potential to mis-associate sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PVT Interface Module (PVT)-Laboratory Automation system Brand names of the
The Issue: Firmware versions have the potential to mis-associate sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity h Interface Module (HSQ)-Laboratory Automation system Brand names of
The Issue: Firmware versions have the potential to mis-associate sample
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL)
The Issue: Certain lots of the Restoris MultiCompartmental Knee (MCK)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ivenix Infusion System (IIS)
The Issue: Fluid ingress that can cause a loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL)
The Issue: Ccertain lots of the Restoris MultiCompartmental Knee (MCK)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom Pak Surgical Procedure Pack: Pak Number & Pak
The Issue: Sterility; Steril surgical procedure packs contain incomplete seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DEVILBISS HEALTHCARE 1025 SERIES OXYGEN CONCENTRATOR
The Issue: The instruction manual is being replaced with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody...
The Issue: Incorrect Number of Calibrator Levels (2) Set for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips DigitalDiagnost C50 -intended for use in generating radiographic images
The Issue: If the PM for the telescopic carriage is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C50 1.1-intended for use in generating radiographic images of
The Issue: If the PM for the telescopic carriage is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MectaLIF ANTERIOR - Lag Plate Flush H10
The Issue: There is a potential for breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQURE Software Versions 2.5.2 2.5.3 2.5.4 2.6.0 2.6.1
The Issue: Due to potential software issue that may result
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MectaLIF ANTERIOR - Lag Plate Flush H14
The Issue: There is a potential for breakage of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems
The Issue: Due to manufacturing issue, Gastrointestinal (GI) Panel may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.