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 38401–38420 of 38,428 recalls
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.
Recalled Item: OEC 9900 Elite
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 8800 Flexiview designed to provide fluoroscopic and spot-film imaging
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Continuous Ventilator/Continuous Ventilator with Respiratory Mechanics
The Issue: The power to the Esprit Display's Backlight is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEHC OEC 8800 Mobile Fluoroscopic X-ray System
The Issue: X-ray units did not meet manufacturer's specification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HiRes 90K devices with Helix Electrodes Model CI 1400-02H The
The Issue: Advanced Bionics is recalling the the HiRes 90K
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiological Image Processing System The system is an aid to
The Issue: The FluoroTrak Spinal Navigation Application on the OEC
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC MiniView 6800 Mobile
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroView 2800
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 9800 Plus Digital
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cannulaide
The Issue: Cannulaide model CA 101 was recalled because the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: No packaging. The device is a computed tomography scanner. Intended
The Issue: When the Extended Display Firled ov View reconstruction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile
The Issue: Biomet is recalling Part Number PT-113950 PT Hybrid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 8800 Flexview
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC 6800 Miniview
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC Uroview 2800
The Issue: Recalled in November 2006 due to several intermittent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Axcess Cranial Screw (sometimes to as the Axcess
The Issue: GE Healthcare is aware of a few instances
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC InstaTrak 3500
The Issue: GE Healthcare had recalled certain OEC InstaTrak 3500
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InstaTrak with Multiple Dataset Navigation
The Issue: Please be aware that this is not a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Qualicheck 1+
The Issue: The barcode for the ABL77 on the insert
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.