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 4761–4780 of 38,428 recalls
Recalled Item: smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with...
The Issue: There is the potential for a disconnection of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex BLUselect
The Issue: There is the potential for a disconnection of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with...
The Issue: There is the potential for a disconnection of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Series CYSC- Cystatin C Reagent -Intended for in vitro
The Issue: Cystatin C Reagent marketed without a 510 (k)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AURORA Surgiscope System. Sterile
The Issue: sheath damage that could lead to tissue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMTech Desktop Laser Engraver
The Issue: Lack of redundant interlocks, missing required labels and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500 AU Clinical Chemistry Analyzer
The Issue: There are two software bug issues with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergetics I-Pack Injection Kit with Drape -For use with Ophthalmic
The Issue: Could not confirm products were exposed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergetics I Pack Injection Kit Custom-Tray for use with Ophthalmic
The Issue: Could not confirm products were exposed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergetics I Pack Injection Kit with Wire Speculum- Tray for
The Issue: Could not confirm products were exposed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synergetics I Pack Injection Kit- Tray for use with Ophthalmic
The Issue: Could not confirm products were exposed to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSE XL TORSO COIL 1.5T. 16-element receive only coil for
The Issue: for coils to heat up and harm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSE XL TORSO COIL 3.0T. 16-element receive only coil for
The Issue: for coils to heat up and harm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil
The Issue: for coils to heat up and harm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dxl 9000 Access Immunoassay Analyzer
The Issue: The analyzers were built with nonconforming USB cables
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Meridian Angled Awl Fixed Product Name: Angled Awl
The Issue: Insufficient weld around the cap component of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trulight 5000/3000 Surgical Light
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iLED 7 surgical lights
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VidiaPort carrying arm
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zyno Medical Z800
The Issue: Zyno Medical has found that certain Z800, Z800F,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.