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 21921–21940 of 38,428 recalls
Recalled Item: AltiVate Reverse INSTRUMENTATION
The Issue: Broken or missing screws and retaining clips. This
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AQUIOS CL Flow Cytometer System
The Issue: The device may process the same sample with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altivate Anatomic(TM) INSTRUMENTATION
The Issue: It was discovered during a surgery that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altivate Anatomic(TM) INSTRUMENTATION
The Issue: It was discovered during a surgery that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altivate Anatomic(TM) INSTRUMENTATION
The Issue: It was discovered during a surgery that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altivate Anatomic(TM) INSTRUMENTATION
The Issue: It was discovered during a surgery that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altivate Anatomic(TM) INSTRUMENTATION
The Issue: It was discovered during a surgery that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NxStage Dialysate Sack: 1) UDI-M535SAK3010
The Issue: May contain endotoxin levels which have been confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare Ceiling Mounted Surgical Light System
The Issue: The device could have a missing spanner nut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips QCPR Meter - used with FR3 Product Usage: The
The Issue: Inform users of correct placement of the disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips QCPR Meter - used with MRx Product Usage: The
The Issue: Inform users of correct placement of the disposable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux VITEK 2 Gram Positive Cefoxitin Screen
The Issue: Customer reports indicated an increase in the rate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph Horizon - PET/CT
The Issue: Error introduced into PET images acquired and reconstructed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proteus 235
The Issue: When switching from Pencil Beam Scanning treatment mode
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ray Station 4.9 Ray Station 5
The Issue: Software issue with Center Beam in Field functionality
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTA-Lyser 240 EIA
The Issue: The device power supply was not manufactured according
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QUANTA-Lyser 240 IFA
The Issue: The device power supply was not manufactured according
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON SC2000 Ultrasound System Product Usage: The SC2000 ultrasound imaging
The Issue: The application may underestimate the EROA (Effective Regurgitant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Berchtold Chromophare Dual Monitor Carrier Arm or Dual Flat Panel
The Issue: The mounts on the monitor may have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity PACS-IW with Universal Viewer Product Usage: Usage: Centricity...
The Issue: that one or more image series may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.