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 7601–7620 of 38,428 recalls
Recalled Item: LINK MP Monoblock Hip Stem
The Issue: Increased force may be required to remove the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3D9-3v Transducer
The Issue: Transducer, an ultrasound system accessory, consists of two
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC...
The Issue: Epoxy used during manufacturing of the LifeSPARC Pump
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Wireless Foot Switch distributed with Philips Allura Xper and Azurion
The Issue: Loss of availability of the wireless foot switch
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Impella RP Flex with SmartAssist intracardiac microaxial blood pump
The Issue: A higher than expected rate of thrombus formation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker 3.0MM Neuro Match Head
The Issue: There is potential the device inside the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker 3.0MM Precision Neuro Match Head
The Issue: There is potential the device inside the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is
The Issue: There is potential the device inside the package
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion FMS Pak
The Issue: Reports of patient injury during use in procedures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Legion FMS Pak
The Issue: Reports of patient injury during use in procedures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Duet External Drainage and Monitoring system
The Issue: Product labeling contains incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter
The Issue: Catheter center lumen was found to have an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.