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 26561–26580 of 38,428 recalls
Recalled Item: 3.5mm Bowed Locking Compression Femur Plates
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CARESCAPE VC150 Vital Signs Monitor
The Issue: A software error on released software versions 1.6.12,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Syngo RT Therapist
The Issue: Software patch installation to address several safety issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMUS
The Issue: Software patch installation to address several safety issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTISTE
The Issue: Software patch installation to address several safety issues
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuLIF PL 8-12mm x 11mm x 27mm x 8 Cage
The Issue: Since Stryker acquired the AccuLIF product in March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuLIF PL 10-16mm x 11mm x 27mm x 8 Cage
The Issue: Since Stryker acquired the AccuLIF product in March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AccuLIF PL 6-9mm x 11mm x 27mm x 8 Cage
The Issue: Since Stryker acquired the AccuLIF product in March
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliVue Patient Monitor Product Usage: The monitors are indicated for
The Issue: If an affected Patient Monitor has been powered
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRI Salicylate Serum Tox Assay
The Issue: Some lots of DRI Salicylate Serum Tox Assay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Custom Cardiovascular System Cardiovascular Procedure Kits labeled...
The Issue: Terumo Custom Cardiovascular Procedure Kits are labeled as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SUNRISE instrument. The INFINITE F50 instrument is a 96-well absorbance
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecan Infinite M1000 PRO The Tecan Infinite M1000 PRO is
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecan Infinite M1000 The Tecan Infinite M1000 is a multifunctional
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tecan Infinite 200. The SUNRISE instrument is a 96-well absorbance
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hydroflex ELISA The HYDROFLEX is a plate washer for 96-well
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite 200 PRO The Tecan Infinite 200 PRO is a
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinite F50 instrument. The INFINITE F50 instrument is a 96-well
The Issue: The batteries have the potential to overheating, melt
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OEC UroView 2800
The Issue: A firmware issue in the supplied LCD workstation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.