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 20781–20800 of 38,428 recalls
Recalled Item: Implant Direct Legacy Implant Closed-Tray Transfer-Concave Profile
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Disinfection unit UV (432332-9020-000) for the Celldiscoverer 7 microscope
The Issue: Under certain circumstances, the firmware makes it possible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Biograph mCT Systems: (a) Biograph mCT S(64)-3R
The Issue: Siemens Medical Solutions USA, Inc., Molecular Imaging business
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EZ1 DSP Virus Kit (48)
The Issue: Underfilled reagent well that could lead to incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL90 FLEX analyzers with software versions 3.3MR1 or below. The
The Issue: The ABL90 FLEX can aspirate Cal 2 solution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis with Laird Cooling Unit for SSFD: Material #
The Issue: Due to a defective sealing, coolant may inflow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee systems with Laird Cooling Unit for SSFD: Material
The Issue: Due to a defective sealing, coolant may inflow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vectris(TM) Trial Screening Lead Kit for Spinal Cord Stimulation
The Issue: This voluntary recall is being conducted due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vectris(TM) Sure Scan(R) MRI Lead Kit for Spinal Cord Stimulation
The Issue: This voluntary recall is being conducted due to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare CARESCAPE Monitor B650
The Issue: When multiple CARESCAPE Monitor B650 units are connected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM/CT 670 DR
The Issue: When your system was installed, the Main disconnect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM/CT 670 Pro
The Issue: When your system was installed, the Main disconnect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery NM/CT 670 ES
The Issue: When your system was installed, the Main disconnect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software Package
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorting-Drive Product Part
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intelligent Peri-Analytical Workstation (HW+SW)
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorting-Drive Professional Part
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software Package
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software Package
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Software Package
The Issue: Sorting-Drive software version 4.2 (released in October 2015)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.