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 8221–8240 of 38,428 recalls
Recalled Item: ICD COBALT XT DR MRI IS1 DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMB1Q1 AMPLIA MRI QUAD US DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD COBALT XT DR MRI IS1 DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR DVFB1D4 VISIA MRI AF US DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR DVFB1D1 VISIA AF MRI US DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMC1QQ COMPIA MRI QUAD US DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD COBALT DR MRI IS1 DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD CROME HF MRI IS1 DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD CROME DR MRI IS1 DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR DVMD3D4 PRIMO MRI
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D VIVA QUAD XT GOLD CTD
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD COBALT HF QUAD MRI IS4 DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMA2D4 CLARIA MRI OUS DF4
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMA1D1 CLARIA MRI US DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMB2D1 AMPLIA MRI OUS DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR DVMC3D1 EVERA MRI S OUS/US DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ICD-VR DVEX3E4 EV ICD EV4 PIVOTAL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBB1D4 VIVA S IS1/DF4 US
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBB1D1 VIVA S IS1/DF1 US
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRT-D DTBA2D1 VIVA XT IS1/DF1 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.