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 13721–13740 of 38,428 recalls
Recalled Item: Three 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: IceSphere" 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: IceRod" 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: IceRod" 1.5 PLUS 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" 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: IceFORCE" 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: 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: IceFORCE" 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: IceRod" He-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: 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: 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: IceRod" 1.5 MRI 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 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: IceSeed" 1.5¿ MRI 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 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: BD PrecisionGlide Needle 30G x 1/2 (0.3 mm X 13mm)
The Issue: BD has confirmed the presence of blood on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MH-200S
The Issue: The firm has identified a problem with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bransist Safire
The Issue: The firm has identified a problem with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips IntelliVue MP2 Patient Monitors (865040) - Product Usage: intended
The Issue: Speakers on IntelliVue X2 and IntelliVue MP2 may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trinias
The Issue: The firm has identified a problem with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.