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 20481–20500 of 38,428 recalls
Recalled Item: 400mL
The Issue: The temperature sensor catheters may be defective in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: P400 PREM U/M 16FR TMPSNS
The Issue: The temperature sensor catheters may be defective in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Cl- Slides
The Issue: The slides failed to meet current claims for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 400mL
The Issue: The temperature sensor catheters may be defective in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEMP SENSE SILICONE 14FR5CC2W
The Issue: The temperature sensor catheters may be defective in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Cl- Slides
The Issue: The slides do not meet the maximum allowable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Cl- Slides
The Issue: The slides do not meet the maximum allowable
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arkon Anesthesia Delivery System with Arkon Software Version 2.70
The Issue: Arkon Anesthesia Delivery System may go into a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: djosurgical Linear Neck Trials with Spring Sides
The Issue: The retaining ring on the neck trials has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use
The Issue: The packaging may not be sealed. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HANDS-OFF Multi-Lumen Central Venous Catheter with Blue FlexTip for use
The Issue: The packaging may not be sealed. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Platinium CRT-D 1741 DF-4
The Issue: Hardware configuration may lead to overconsumption, followed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ChloraPrep With Tint
The Issue: A nonsterile bulk product designated for further processing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Platinium CRT-D 1711 DF-1
The Issue: Hardware configuration may lead to overconsumption, followed by
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic CD HORIZON Spinal System is intended to help provide
The Issue: This lot has incorrectly been laser marked both
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mallinckrodt Pharmaceuticals INOflo DS
The Issue: INOmeters affixed to the INOflo cylinders in Lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UroLift System Number: UL400-4 Tray Contents: UroLift System
The Issue: Upon implant deployment, the Capsular Tab may not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Fast Release Varnish
The Issue: Product has an unpleasant flavor due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex First Breath Adult Nasal Cannula
The Issue: "Manufactured" and "Use By" labels are transposed incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smiths medical portex First Breath Adult Nasal Cannula
The Issue: "Manufactured" and "Use By" labels are transposed incorrectly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.