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 2961–2980 of 38,428 recalls
Recalled Item: Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXperFD20/10 System Code: (1) 722029
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M20 System code: (1) 722224 (2) 722079 (3)
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXperFD20/15 System Code: (1) 722058
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 5 M12 System Code: (1) 722227 (2) 722231
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD20/20 System Code: (1) 722038
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allura Xper FD10C System Code: (1) 722001
The Issue: safety issue with the AD7 and AD7X
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DxC 500 AU Clinical Chemistry Analyzer
The Issue: Beckman Coulter has identified an issue which prevents
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Pyxis: MedFlex
The Issue: Automated dispensing device labeling is being updated to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Intact Vascular Tack Endovascular System
The Issue: Use of Tack Endovascular system, designed to treat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.