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 8661–8680 of 38,428 recalls
Recalled Item: Titan NB Infra Zero Ang 16cm
The Issue: A decrease in wall thickness has the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPIOX NX19 Hollow Fiber Oxygenator
The Issue: Some Capiox NX, RX and FX Oxygenators may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4
The Issue: Not able to achieve desired pressure and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4
The Issue: Not able to achieve desired pressure and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4
The Issue: Not able to achieve desired pressure and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPIOX FX25 Hollow Fiber Oxygenator
The Issue: Some Capiox NX, RX and FX Oxygenators may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAPIOX RX15 Hollow Fiber Oxygenator
The Issue: Some Capiox NX, RX and FX Oxygenators may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy EV300 Portable Electric Ventilator
The Issue: The accuracy of delivered oxygen may deviate below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo Universal Portable Electric Ventilator
The Issue: The accuracy of delivered oxygen may deviate below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4
The Issue: Not able to achieve desired pressure and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4
The Issue: Not able to achieve desired pressure and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Evo O2 and LifeVentEVO2 Portable Electric Ventilator
The Issue: The accuracy of delivered oxygen may deviate below
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4
The Issue: Not able to achieve desired pressure and not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Instructions for Use for the following Leksell Stereotactic System and
The Issue: The incorrect IFU was distributed with the devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Express Mini 500 Dry Seal Chest Drain
The Issue: The Instructions for Use (IFU) for the Pneumostat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Color Cuff Single Port
The Issue: Increased incidence of disposable tourniquet cuffs "not able
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium Pneumostat Chest Drain Valve
The Issue: The Instructions for Use (IFU) for the Pneumostat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omega Medical Imaging Elevating Monitor Suspension
The Issue: An actuator separated from the pivot mechanism on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Omnipod 5 Automated Insulin Delivery System
The Issue: An error message was received when using the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioPlex 2200
The Issue: APLS IgM reagent kits were packaged with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.