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 38381–38400 of 38,428 recalls
Recalled Item: Screw Tulip
The Issue: The tulip portion of the screw assembly can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Navitrack System - OS Knee Universal
The Issue: Zimmer CAS voluntarily conducted a retrospective recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quadra S Offset Broach Handle The offset broach handle is
The Issue: Medacta USA Inc has initiated a recall on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEHC OEC Injection Cable for MedRad Provis V Contrast Injector.
The Issue: GE initiated a correction to the instructions/use due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model...
The Issue: Sechrist conducted a field upgrade on the hyperbaulic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sechrist Monoplace Hyperbaric Chamber with Electronic Control Module Model...
The Issue: Sechrist conducted a field upgrade on the hyperbaulic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory...
The Issue: Distribution of a product that did not meet
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Precision MPi is an all-digital multipurpose tilt-C x-ray system
The Issue: It was discovered that the Remote Touch Panel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Navitrack¿ System - OS Knee Universal
The Issue: ZIMMER CAS voluntarily conducted a retrospective recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Benchmark XT/LT and Discovery XT Model Numbers: N750-BMK-FS
The Issue: Ventana Medical System is initiating the recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sesamoid Plasty
The Issue: Zimmer CAS voluntarily conducted a retrospective recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannulaide
The Issue: Cannulaide recalled May 2008 due to improper seal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TSX-301A/2 Aquilion One CT System. The TSX-30IAl2 is a whole
The Issue: The SureStart function may not operate in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EXCELART Vantage
The Issue: The status display in the sequence queue window
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Straight Impactor - Dorado IBC
The Issue: During two separate occasions an impactor plate on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Finger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To
The Issue: The outer jacket is receding away from the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEMINI PET/CT System
The Issue: The reason for this inspection is to determine
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PT Link Waterbath
The Issue: Dako is recalling the PT Link Waterbath because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toshiba CT systems
The Issue: The systems all have a similar table control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9800
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.