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 2181–2200 of 38,428 recalls
Recalled Item: OBM00002 OBM DAB (Digital Acquisition Box) Product Name:
The Issue: Electrode placement labels on the Digital Acquisition Box
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800 Infusion System. Intended to provide intravenous infusion of parenteral
The Issue: Unreleased software versions were installed on distributed devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SmartRelease ESTR (Endoscopic soft tissue release system)
The Issue: that the blade can unintentionally cut tissue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral
The Issue: Unreleased software versions were installed on distributed devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800W Infusion System. Intended to provide intravenous infusion of parenteral
The Issue: Unreleased software versions were installed on distributed devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800F Infusion System. Intended to provide intravenous infusion of parenteral
The Issue: Unreleased software versions were installed on distributed devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HardyCHROM CRE
The Issue: Identified lots failed incoming quality control testing. Lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Powered Laser Surgical Instrument Product Name: Soltive SuperPulsed
The Issue: for thermal incident including an unexpected occurrence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Powered Laser Surgical Instrument Product Name: SOLTIVE Premium
The Issue: for thermal incident including an unexpected occurrence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Powered Laser Surgical Instrument Product Name: Soltive Reusable
The Issue: for thermal incident including an unexpected occurrence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Powered Laser Surgical Instrument Product Name: SOLTIVE Pro
The Issue: for thermal incident including an unexpected occurrence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affinity 4 Birthing Bed
The Issue: There is a potential for improper crimps on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PhenoMATRIX
The Issue: AI-powered bacterial culture plate interpretation and workup software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAFE-T-FILL Micro Capillary Blood Collection
The Issue: All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
The Issue: Recent post-market surveillance data suggests a possible association
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dexcom G7 iOS Application
The Issue: A bug in the 2.7.0 version of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Testosterone assay
The Issue: Inadequate preventative maintenance (PM) performed on the scales
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog
The Issue: Due to labeling error. Product incorrectly labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD BBL CultureSwab EZ Collection and Transport System
The Issue: Swabs for specimen collection may be prone to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChannelCheck Convenience Pack
The Issue: During endoscope surveillance monitoring, a user facility identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.