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 6121–6140 of 38,428 recalls
Recalled Item: TFNA Femoral Nail 11mm
The Issue: Products not sterilized, sterility cannot be confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stay-safe /Luer Lock Adapter 4 in
The Issue: The peroxide cross-linked tubing has leachables identified as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stay-safe /Luer Lock Catheter Ext. 18 in
The Issue: The peroxide cross-linked tubing has leachables identified as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stay-safe /Luer Catheter Ext. 6 in
The Issue: The peroxide cross-linked tubing has leachables identified as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stay-safe /Luer Lock Catheter Ext. 12 in
The Issue: The peroxide cross-linked tubing has leachables identified as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stay-safe /Safe Lock Catheter Ext. 12 in
The Issue: The peroxide cross-linked tubing has leachables identified as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CVS Health Waterproof Wound Tracking Dressing
The Issue: Product failed sterility testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Battery Mobile X-ray Unit EASY MOVING Model with telescopic column 3.1
The Issue: interference with the anti-fall system
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invacare Homecare Series Bed and Invacare G-Series Beds Containing Component
The Issue: Invacare Homecare & G-Series Bed Components identified with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 5600 Integrated System (New and )
The Issue: For Aspiration from Unintended Sample Container During
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT7600 Integrated System
The Issue: For Aspiration from Unintended Sample Container During
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS 3600 Immunodiagnostic System (New and )
The Issue: For Aspiration from Unintended Sample Container During
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: for catheter disconnection from the patient line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: for catheter disconnection from the patient line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: for catheter disconnection from the patient line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tensive Conductive Adhesive Gel
The Issue: Five complaints were received related to viscosity of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: for catheter disconnection from the patient line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring System
The Issue: for catheter disconnection from the patient line
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Epidural tray. PERIFIX 17 Ga. x 3-1/2 in. (90 mm) Tuohy
The Issue: Kits should contain Filter Straws with Standard Luer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.