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 13701–13720 of 38,428 recalls
Recalled Item: IceRod" 1.5 CX 90¿ Cryoablation Needle¿
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Five IceSphere" Prostate Cryoablation Kit
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IcePearl" 2.1 CX Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSeed" 1.5 MRI Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceRod" 1.5 i-Thaw" Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSeed" 1.5 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSphere" 1.5 CX 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSphere" 1.5 Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSphere" 1.5 S 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IcePearl" 2.1 CX L 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceFORCE" 2.1 CX 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceRod" 1.5 PLUS 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceRod" Prostate Cryoablation Kit
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Five IceRod" i-Thaw" Prostate Cryoablation Kit
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceEDGE" 2.4¿ 90p¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceSeed" Prostate Cryoablation Kit
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Three IcePearl" 2.1 CX Prostate Cryoablation Kit
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceRod" 1.5 MRI Cryoablation Needle¿
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceFORCE" 2.1 CX Prostate Cryoablation Kit
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IceRod" 1.5 90¿ Cryoablation Needle
The Issue: Complaint trend regarding needle shaft gas leaks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.