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 15081–15100 of 38,428 recalls
Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X40MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X45MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X40MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants VITAL MIS TAB BREAKER
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants CANN BL POLY EXT 8.5X50MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X40MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 6.5X50MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 7.5X35MM
The Issue: There are reports of inadequate locking of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AC Powered hospital adjustable bed.
The Issue: Hazard of Unsupervised Patient being out of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo Midline Convenience Kits - Product Usage: These introducers are
The Issue: Certain AngioDynamics PICC Kits contain BD PosiFlush SF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC and Xcela PICC Maximal Barrier Nursing Kits -
The Issue: Certain AngioDynamics PICC Kits contain BD PosiFlush SF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard SRHS Central Line Kit
The Issue: There is a potential for the product to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo PICC and Xcela PICC Convenience Kits - Product Usage:
The Issue: Certain AngioDynamics PICC Kits contain BD PosiFlush SF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BioFlo Midline Catheter and BioFlo Maximal Barrier Kits - Product
The Issue: Certain AngioDynamics PICC Kits contain BD PosiFlush SF
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard SRHS GIC Port A Cath
The Issue: There is a potential for the product to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Chemistry Fructosamine Reagent (FRUC)
The Issue: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Enzymatic Creatinine_2
The Issue: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Fructosamine Reagent (FRUC)
The Issue: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Enzymatic Creatinine
The Issue: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista Enzymatic Creatinine
The Issue: The presence of N-acetyl-p-benzoquinone imine (NAPQI), a metabolite
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.