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 33281–33300 of 38,428 recalls
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMO TECNIS CL Foldable Silicone IOL with OptiEdge Design
The Issue: Units may be labeled with the incorrect diopter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Agfa Digital Radiography X-Ray System DX-D 100 Product Usage: Is
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeVilbiss Model DV5x Series CPAP units. For use in treating
The Issue: A limited number of DV5x Series CPAP units
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cooper Surgical TAMPA CATHETER 5 French 33 cm. Intended for
The Issue: Sterility of the device may be compromised due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The NAV3i Platform Power Box supplies the electrical components with
The Issue: The Stryker NAV3i Platform Power Boxes produced between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic M-IV Mammography System
The Issue: Selenia Full Field Digital Mammography System defective relay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Stryker NAV3i Platform is a mobile cart platform consisting
The Issue: The Stryker NAV3i Platform Power Boxes produced between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hologic Selenia Full Field Digital Mammography System: SEL-00002
The Issue: Selenia Full Field Digital Mammography System defective relay
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.