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 22201–22220 of 38,428 recalls
Recalled Item: ARCHITECT c8000 Cuvette Segment
The Issue: There is a potential to generate falsely depressed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c4000 Cuvette Segment
The Issue: There is a potential to generate falsely depressed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT c16000 Cuvette Segment
The Issue: There is a potential to generate falsely depressed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Remel Shigella sonnei Phase 1 & 2 Agglutinating Serum
The Issue: The serum may fail to agglutinate within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cascade Abrazo aPTT Test Card
The Issue: Some of the cards show occasional shorter clot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6.5mm x 125mm x 16mm Cannulated Screw
The Issue: One lot of 3.5mm x 24mm Cortical Locking
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT SR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE SR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VISIONIST CRT-P Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTRUA 2 EL DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE MRI EL DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VALITUDE CRT-P Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PROPONENT EL DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE MRI DR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACCOLADE MRI SR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ESSENTIO SR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ALTRUA 2 SR Pacemaker
The Issue: Boston Scientific has received reports of intermittent over-sensing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.