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 321–340 of 38,428 recalls
Recalled Item: Allura Xper FD20
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: Allura Xper FD10C
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10/10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/20
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10/10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is
The Issue: for defect for Asserachrom HPIA lot 271288,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 Biplane
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum Duo Infusion System
The Issue: ICU Medical received one lot of defective primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 OR Table
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20 Biplane
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20
The Issue: Philips has identified that in a limited number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Medical Linear Accelerator Product Name: Elekta Synergy
The Issue: Due to a manufacturing issue and electrical grounding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff
The Issue: Due to damage to outer tray that can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning
The Issue: Due to an error when defining a new
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning
The Issue: Due to an error when defining a new
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.