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 1881–1900 of 38,428 recalls
Recalled Item: QuickVue: Dipstick Strep A Test: 50T
The Issue: Dipstick strep A test has potential for false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MI Cancer Seek UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer
The Issue: Due to an incorrect test results provided that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-view video laryngoscope. Model Number: 8008000. The i-view video laryngoscope
The Issue: for faulty devices as a result of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SmartLink Software loaded on SmartSync Patient Connector
The Issue: A software update for Medtronic CareLink SmartSync Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic SmartLink software loaded on CareLink SmartSync Device Manager
The Issue: A software update for Medtronic CareLink SmartSync Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK and LYFO DISK
The Issue: Affected products contain Staphylococcus epidermidis instead of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SwabFlush Prefilled Syringe with ICU Medical SwabCaps
The Issue: SwabFlush syringes are affected by the ICU Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InPen App
The Issue: Medtronic MiniMed, Inc. is recalling InPen App for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD PhaSeal Injector Luer (N30C)
The Issue: Closed system drug transfer devices were shipped to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
The Issue: Reports of slow increase of CO2-curve when gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
The Issue: Reports of slow increase of CO2-curve when gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
The Issue: Reports of slow increase of CO2-curve when gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
The Issue: Reports of slow increase of CO2-curve when gas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biofinity XR Toric Contact Lens
The Issue: Lens blisters may have an incomplete or leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biofinity Toric Multifocal Contact Lens
The Issue: Lens blisters may have an incomplete or leaking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Volcano Visions Digital IVUS Catheter: PV.014P (Platinum)
The Issue: Reports of IVUS catheter and guide wire entanglement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estrone RIA Catalog Number DSL8700 UDI Code: 15099590211615 Estrone RIA
The Issue: Estrone RIA kit lots may rarely give falsely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits
The Issue: Affected convenience kits contain BD ChloraPrep Clear -
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Estrone RIA
The Issue: A specific lot of bovine serum albumin (BSA)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience Kits
The Issue: Affected convenience kits contain BD ChloraPrep Clear -
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.