FDA says ‘do not use’ Hologic BioZorb Markers

In an updated safety communication dated October 25, the FDA states: “The U.S. Food and Drug Administration is alerting consumers, health care providers and health care facilities not to use BioZorb Markers and BioZorb LP Markers by Hologic (HOLX) Inc. On October 25, 2024, Hologic announcedExternal Link Disclaimer 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. The FDA is issuing this communication to help ensure you are aware of the manufacturer’s most recent recall notice and the recommended actions.”