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 13501–13520 of 38,428 recalls
Recalled Item: ACUITY Universal Cutter
The Issue: Boston Scientific (BSC) is retrieving five Model 7060
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Penumbra JET 7 KIT Reperfusion Catheter+Penumbra Hi-Flow Aspiration Tubing REF
The Issue: The catheter may become susceptible to distal tip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected)
The Issue: Eltrombopag Interference for VITROS Chemistry Products TP Slides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products TP Slides- IVD measure total protein (TP)
The Issue: Eltrombopag Interference for VITROS Chemistry Products TP Slides
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle Cups
The Issue: Certain Pinnacle Cup devices may potentially exhibit an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX Bivona Cuffless Neonatal/Pediatric FlexTend Tracheostomy Tube
The Issue: A specific model and lot number of Bivona
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENOVO Venous Stent System 9F Product Description(REF)/dimension: VENEL14040...
The Issue: Reports of the proximal end of the stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENOVO Venous Stent System 8F Product Description(REF)/dimension: VENEL10040...
The Issue: Reports of the proximal end of the stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VENOVO Venous Stent System 10F Product Description(REF)/dimension:...
The Issue: Reports of the proximal end of the stent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRYTIME MEDICAL REBOA Catheter Introducer Kit
The Issue: There is a potential that a catheter convenience
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EliA dsDNA Well - Product Usage: intended for the In-Vitro
The Issue: Decreased values for EliA ANA Positive Control when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Neuroreader Medical Image Processing Software - Product Usage: intended to
The Issue: The Neuroreader has been distributed with a reference
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Yukon Polyaxial Screw Size 4.0x26mm (catalog number 7601-04026)
The Issue: The Yukon polyaxial screw used in the Yukon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bactiseal Ventricular Catheter with Bactiseal Shunt System - Product Usage:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bactiseal Endoscopic Ventricular Catheter: EVC- Catheter is designed for use
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: therascreen PIK3CA RGQ PCR Kit (23) US IVD product- aid
The Issue: Kit may generate false Q546R mutation positive results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FUJIFILM Synapse PACS Software: versions 7.0.0 and 7.0.1 - Product
The Issue: The software does not update measurements and calculations
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Reliance Vision Single-Chamber Washer/Disinfector - Product Usage: intended...
The Issue: The electrical contactor component present in the drying
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VERITAS Collagen Matrix - Product Usage: intended for use in
The Issue: VERITAS Collagen Matrix 12x25 cm Patches may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products CKMB Slides: (1)VITROS CKMB Slides (60 Slide
The Issue: VITROS Chemistry Products CKMB Slides Potential for Falsely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.