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 5221–5240 of 38,428 recalls
Recalled Item: Cobalt XT DR MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT XT VR MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIRRO MRI VR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT DR MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CROME VR MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIRRO MRI DR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT VR MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMO MRI DR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIRRO MRI VR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT XT HF CRT-D MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVERA S VR
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product not distributed in the US. Implantable Cardioverter Defibrillators: a.
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT XT HF QUAD CRT-D MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CROME HF QUAD CRT-D MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobalt XT HF CDT-D MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVERA MRI S DR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PRIMO MRI VR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBALT XT HF QUAD CRT-D MRI SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MIRRO MRI DR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EVERA MRI S DR SureScan
The Issue: for manufacturing defect. Weld crack led to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.