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 34921–34940 of 38,428 recalls
Recalled Item: Microscan plus Negative Breakpoint Combo 4 Sold outside of US
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan plus Negative Urine Combo 4 Sold outside of US
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan¿ Synergies
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan¿
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage:
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan plus Negative Combo 3 Sold outside of US only.
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage:
The Issue: Confirmed increase in false susceptible and false intermediate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Carestream DRX Evolution System (Standard Q) The DRX-Evolution System (Standard
The Issue: Carestream received a report of an exposure being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iba COMPASS SW Version 3.0
The Issue: The development partner of IBA informed that there
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FSE Image Upgrade Kit
The Issue: The FSE Image Upgrade kit (part 92019C) is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEGRIS system Four labels of the Tegris System include: Emergency
The Issue: MAQUET has identified a potential issue that might
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The FL23SE Bed is an AC-powered adjustable hospital bed with
The Issue: The nurse call cable (Part Number: QDF23-0571) on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vision One Laser System Model GA-0025020
The Issue: Lumenis has initiated a recall on certain models
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCU-CHECK FastClix Lancing Device. It is intended for use in
The Issue: Internal Roche inspections have revealed that after the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia S
The Issue: The detectors on the Symbia S and Symbia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Symbia T Series SPECT + CT Product Usage 1) SPECT:
The Issue: The detectors on the Symbia S and Symbia
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Intact PTH Calibrator (6 pack)
The Issue: PTH Calibrator packaged with only high calibrator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile
The Issue: Issues with the Ingenuity TF PET/CT Software Version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare
The Issue: GE Healthcare has become aware of a potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zeppessis' reprocessed single-use manifolds (filters) for the Stryker Neptune 1
The Issue: Zeppessis' reprocessed single-use manifolds (filters) for the Stryker
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.