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 8201–8220 of 38,428 recalls
Recalled Item: CRTD DTMA1D4 CLARIA MRI 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 DVMD3D1 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: ICD CROME 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-DR DDBB1D4 EVERA XT 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: CRTD COBALT XT HF 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-DR DDBB1D1 EVERA XT 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: ICD-DR DDMB2D4 EVERA MRI XT IS-1/DF4 INT
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 DVBC3D1 EVERA S IS1/DF1 GLOB
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 DVFC3D1 VISIA AF 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: CRTD DTMB2Q1 AMPLIA MRI QUAD 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 DVBB1D4 EVERA XT 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: CRTD VIVA QUAD XT CUST PARY GOLD
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 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 COBALT HF 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: CRT-D DTBA1D4 VIVA XT 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: CRTD DTMC2D4 COMPIA 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: ICD-VR DVBB1D1 EVERA XT 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: ICD-DR DDMB2D1 EVERA MRI XT 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: CRT-D DTBB2D1 VIVA S IS1/DF1 INTL
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRTD DTMC2D1 COMPIA MRI OUS DF1
The Issue: There is a rare potential for reduced- or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.