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 34581–34600 of 38,428 recalls
Recalled Item: VERSYS HERITAGE FEM STEM
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6 DEGREE COCR FEM HEAD (various sizes) and 6 DEG UNIPOLAR FEMORAL HE
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ITST ANTI-ROTATION SCREW and FEM IM NAIL (10MM
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE.
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FEM HD ION (various sizes)
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODULAR CUP NEUTRAL LINER MODULAR CUP 10 DEGREE LIN MODULAR
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Item codes starting with 001930 LAG SCR 12.7D X 55MM SHOR up to 155 MM
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MODULAR AUSTIN MOORE FENE. Item codes starting with 45502001
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOORE HIP PROS LONG FENES
The Issue: Zimmer recently conducted a review of all historic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System: One 1 g
The Issue: Incorrect instructions for use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD GeneOhm Cdiff Assay
The Issue: An incorrect reagent was packed with an in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRUFILL¿ n-Butyl Cyanoacrylate (n-BCA) Liquid Embolic System
The Issue: Incorrect instructions for use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HGE Healthcare Patient Monitor B30
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Vivid E9 ultrasound system. GE Vivid E9 is a
The Issue: GE became aware of a potential safety issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Computed Tomography X-Ray System
The Issue: If the couch, with the footrest extension attached,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Safire Duo Ablation Catheter MediGuide Enabled
The Issue: St. Jude Medical Cardiovascular and Ablation Technologies Division
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: US Safire Duo Ablation Catheter MediGuide Enabled
The Issue: St. Jude Medical Cardiovascular and Ablation Technologies Division
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Drill (Fluted-Hard Bone)
The Issue: A review of complaints identified a trend for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VariAx Compression Plating System
The Issue: Stryker received two reports indicating that during screw
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed
The Issue: Nanosphere has received several reports relating to an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.