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 15021–15040 of 38,428 recalls
Recalled Item: Multifire VersaTrack Auto Suture Hernia Stapler
The Issue: The product is recalled due to a manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOL3655 Simplexa VZV Swab Direct - Product Usage: is intended
The Issue: Due to a software malfunction in the Multi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOL2150 Simplexa HSV 1&2 Direct -CSF -Genital Swab -Cutaneous /
The Issue: Due to a software malfunction in the Multi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOL3650 Simplexa VZV Direct - Product Usage: is intended for
The Issue: Due to a software malfunction in the Multi
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irix-C Forceps Inserter
The Issue: The strike plate fractured off from the forceps
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alinity C
The Issue: There is a potential to generate incorrect patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multifire Endo Hernia 0 12mm Stapler with 4.8mm Disposable Loading Unit
The Issue: The product is recalled due to a manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Type S Extension For use with Varian
The Issue: for disengagement of the Varian Style Type-S
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multifire Endo Hernia 0 12mm Stapler with 4.0mm Disposable Loading Unit
The Issue: The product is recalled due to a manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Multifire VersaTrack Auto Suture Hernia Stapler
The Issue: The product is recalled due to a manufacturing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Confida Expandable Sheath
The Issue: Increased risk of events associated with vascular complications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL80-FLEX CO-OX 393-841 Box Label
The Issue: Barcode readers on ALB900 and ABL800 analyzers used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABL80-FLEX-393-839 Box Label
The Issue: Barcode readers on ALB900 and ABL800 analyzers used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Product Performance Verifier I
The Issue: Multiple coatings of VITROS Chemistry Products AMYL Slides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Product AMYL Slides Reagent
The Issue: Multiple coatings of VITROS Chemistry Products AMYL Slides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Product Performance Verifier II
The Issue: Multiple coatings of VITROS Chemistry Products AMYL Slides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Product AMYL Slides Reagent
The Issue: Multiple coatings of VITROS Chemistry Products AMYL Slides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Comprehensive VRS Inserter
The Issue: The product is being recalled due to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The OEC 9900 C-Arm is designed to provide fluoroscopic and
The Issue: GEHC Surgery became aware that some users of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: uCT 760 System
The Issue: Two issues were identified with the computed tomography
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.