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 14121–14140 of 38,428 recalls
Recalled Item: Hurricane RX Biliary Balloon Dilatation Catheter Catalog . M00545890
The Issue: RX tunnel component (black sheath) may detach from
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Red Dot Monitoring Electrode with Foam Tape - Product
The Issue: Corrosion could cause performance failures in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel -
The Issue: Corrosion could cause performance failures in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Red Dot Monitoring Electrode with Foam Tape - Product
The Issue: Corrosion could cause performance failures in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel -
The Issue: Corrosion could cause performance failures in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Red Dot Monitoring Electrode with 4mm Adapter - Product
The Issue: Corrosion could cause performance failures in the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Quick Release Gait Belt
The Issue: The buckle on the Gait Belt may break
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Monitron II Waveform Analyzer
The Issue: Note this recall occurred in 2020 and 2021
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard 3F SL PowerMidline Full Kit CE-indicated for short term
The Issue: Kits do not contain the stylet/T-lock assembly indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Sterilizable Defibrillator Paddles
The Issue: The periodic Paddle Checks recommended in the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Sterilizable Defibrillator Paddles
The Issue: The periodic Paddle Checks recommended in the Instructions
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard 3F SL PowerMidline Basic Kit CE-indicated for short term
The Issue: Kits do not contain the stylet/T-lock assembly indicated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Nexiva Closed IV Catheter System Dual Port (20 GA
The Issue: Dull/blunt needles within the IV Catheter System may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MR Coils The MR Coil is intended to be used
The Issue: The labels have been mistakenly printed with an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #650301023
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #650301018
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #65021652
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #650600111
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #65220955
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kit Model #650304917
The Issue: Non-sterile kits intended to be sterilized prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.