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 2821–2840 of 38,428 recalls
Recalled Item: Access 2 Immunoassay Analyzer
The Issue: Beckman Coulter identified that an issue for Access
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aortic Root Cannula: 1. DLP Aortic Root Cannula A. CANNULA
The Issue: Unexpected loose material in the male luer used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rotarex Atherectomy System and Instructions for Use
The Issue: Atherectomy Catheter eIFU updated to clarify and emphasize
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Sigma Spectrum Infusion System (V6 Platform)
The Issue: There is the potential for missing motor mounting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software
The Issue: There is the potential for missing motor mounting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelePACS (Image Fusion Module) - InteleViewer
The Issue: A software application that receives digital images and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRANI PACK
The Issue: During an internal investigation, ACS was unable to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL LMW Heparin Controls
The Issue: Multiple complaints indicating lower than expected quality control
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital
The Issue: Due to issues associated with data migration of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TBS Osteo Product Name: TBS iNsight Model/Catalog Number:
The Issue: variability in calculations from fast array scans
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro
The Issue: Multi-Function Ventilators were serviced using incorrect parts which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Access Erythropoietin (EPO)
The Issue: Affected lot (439363) exhibited a negative dose drop
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIFEPAK 20e The AED mode is to be
The Issue: Incorrect keypad was incorrectly installed onto a defibrillator/monitor
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Banner University Med Ctr. Product Name: Cardiac Cath
The Issue: Sterility assurance with procedure trays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Banner Health Systems Product Name: Cysto Pack Model/Catalog
The Issue: Sterility assurance with procedure trays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Banner Health Systems Product Name: Lap Pack -
The Issue: Sterility assurance with procedure trays
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Numerous models of nonsterile hemostatic forceps: (1)
The Issue: The forceps have been used in ways not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Numerous models of nonsterile hemostatic forceps: (1)
The Issue: The forceps have been used in ways not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Numerous models of nonsterile hemostatic forceps: (1)
The Issue: The forceps have been used in ways not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.