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 11661–11680 of 38,428 recalls
Recalled Item: BD Nexiva
The Issue: There is a breach in the product packaging
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vit Kit-Freeze is intended for use in assisted reproductive procedures
The Issue: Due to a component in kit being labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vit Kit-Freeze is intended for use in assisted reproductive procedures
The Issue: Due to a component in kit being labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit: Central Line Dres Change 20/Cs
The Issue: The ChloraPrep 3ml kit component has a shorter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chesapeake Anterior Lumbar (AL) Removal Tool
The Issue: Units may arrive with missing pins and/or in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: The Helium Indicator on the Cardiosave display may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
The Issue: The Helium Indicator on the Cardiosave display may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: The Cardiosave IABP may unexpectedly shut down when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue Intra-Aortic Balloon Pump (IABP)
The Issue: The Cardiosave IABP may unexpectedly shut down when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nox T3s Recorder - Product Usage: intended for ambulatory recording
The Issue: Error in the device firmware results in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heparin
The Issue: Incorrect labeling, specifically, expandable endoprosthesis labeled as 8
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ultra-Myossage Lotion 1-gallon bottle
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GEL CONDUCTOR
The Issue: Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cobas EGFR Mutation Test v2-Somatic gene mutation detection system Catalog
The Issue: False Mutation Detected results for the exon 20
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flower E-Kit
The Issue: Product kit missing CDG 200 (Cannulated Countersink for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ELI
The Issue: The devices malfunction under specific operator workflows
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSX0030H
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSX0025A
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSXE0030
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REF/Catalogue Number GSX0020A
The Issue: Septal Occluders contain the incorrect expiration date. Product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.