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 10201–10220 of 38,428 recalls
Recalled Item: Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental
The Issue: for the incorrect screw to be included
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal limb holders: (1) DeRoyal Limb Holder
The Issue: The webbing strap was laced improperly through the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: (1) GE Centricity Universal Viewer 6.0
The Issue: Inaccurate Distance and Area measurements with use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips EPIQ Ultrasound Systems (various models) used in conjunction with
The Issue: Retroactive: Ultrasound may experience an unexpected automatic reboot,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System
The Issue: Update to IFU provides a manual deployment workaround
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Exacta-Mix 2400 compounding system
The Issue: There is a potential for leaking valves on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARIES SARS-CoV-2 Assay
The Issue: SARS-CoV-2 assay that detects SARS-CoV-2 ORF1ab and N
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier
The Issue: Application error problems: Rebalance scope message: 1.Rebalancing process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas e801 Immunoassay Analyzer
The Issue: Software issue resulting in signals and sample test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Grappler Suture Anchor
The Issue: Suture anchor may break upon insertion, which could
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 / MYLA VITEK 2 Software versions 8.01
The Issue: There are 7 reported software anomalies that may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProPlan CMF Anatomical Model
The Issue: MU22-INA-DUQ case was labeled as MU22-INA-DUQ but was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surpria 64: Software Version V3.11
The Issue: Error 00003050 or 00003052 may occur during scanning,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SCENARIA View: Software Version V1.08
The Issue: Error 00003050 or 00003052 may occur during scanning,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surpria: Software Version V3.11
The Issue: Error 00003050 or 00003052 may occur during scanning,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TaperFit Stem
The Issue: Some of the devices did not pass fatigue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Sensis or Sensis Vibe Combo systems as follows: System
The Issue: The Sensis Signal Input Box provides hooks as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HXBL/WETEX/Genesis Biomedical Viral Transport Container
The Issue: Distributed VTM outside of VTM Guidance and without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HXBL/WETEX/Genesis Biomedical Viral Transport Container
The Issue: Distributed VTM outside of VTM Guidance and without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HXBL/WETEX/Genesis Biomedical Viral Transport Container
The Issue: Distributed VTM outside of VTM Guidance and without
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.