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 9621–9640 of 38,428 recalls
Recalled Item: 2.5 mm LifePort Endotracheal Tube Adapters 10-pack
The Issue: Some adaptors, for use with high frequency ventilators,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V. Mueller ROUND HANDLE BAYONET BIPOLAR FORCEPS
The Issue: BD has determined that the Instructions For Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V. Mueller TITANIUM ROUND HANDLE BAYONET BIPOLAR FORCEPS
The Issue: BD has determined that the Instructions For Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FAST System and the FAST PBC Prep Cartridge together are a closed
The Issue: Device exceeds the limitations of a Class I
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product
The Issue: Due to Customer Convenience Kits containing 3M Steri-Drape
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used
The Issue: During accelerated shelf-life extension studies it was noted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7
The Issue: Occlusion (blockage) of the bubble inlet port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in
The Issue: Update to the carryover avoidance technical bulletin to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IgA Immunoturbidimetric Assay- In vitro determination of IgA and IgM
The Issue: Update to the carryover avoidance technical bulletin to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter
The Issue: Occlusion (blockage) of the bubble inlet port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm)
The Issue: Occlusion (blockage) of the bubble inlet port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420
The Issue: Occlusion (blockage) of the bubble inlet port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm)
The Issue: Occlusion (blockage) of the bubble inlet port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter
The Issue: Occlusion (blockage) of the bubble inlet port of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Electrocardiograph
The Issue: One ELI 380 Electrocardiograph intended to be used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alcon Custom Pak Surgical Procedure Pack
The Issue: Due to difficulty removing the liner on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aero Blue Performance Surgical Gown
The Issue: open seal pouches compromising sterility resulting in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Unity Total Knee System. Used for knee prosthesis in total knee replacement
The Issue: The internal packaging system for devices may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLUTION MP Tibial Bases
The Issue: One confirmed incident has been received that ETPKN2PL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVOLUTION MP Tibial Bases
The Issue: One confirmed incident has been received that ETPKN2PL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.