Do Not Use BioZorb Marker Implantable Radiographic Marker Devices – FDA Safety Communication

The U.S. Food and Drug Administration (FDA) issued a safety communication to alert consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers by Hologic Inc. On October 25, 2024, Hologic announced a voluntary recall for removal of all lots of unused BioZorb Markers.

The recall is due to reports of serious adverse events occurring in patients who had the devices implanted in breast tissue.

This safety communication provides:

• Information on recalled products
• Recommendations for patients with a BioZorb Marker and their caregivers
• Recommendations for health care providers and facilities
• The actions the FDA is taking to address the issue
• Instructions for reporting problems with BioZorb Markers to the FDA

Questions?

If you have questions about this safety communication, contact the Division of Industry and Consumer Education.