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# Hologic BioZorb Marker Recall is Class 1
- URL: https://www.fdaweb.com/hologic-biozorb-marker-recall-is-class-1/
- Published: 2024-05-22T12:00:00.000Z
- Updated: 2026-09-14T14:31:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5157042

FDA says the Hologic 3/13 recall (correction, not product removal) of nine BioZorb markers due to complications and adverse effects with implanted devices is Class 1\. An agency [notice](https://www.fda.gov/medical-devices/medical-device-recalls/hologic-inc-recalls-biozorb-marker-due-complications-implanted-devices?utm%5Fmedium=email&utm%5Fsource=govdelivery) says the 53,492 devices recalled in the U.S. were distributed between 4/29/2019 and 4/1/2024.

The notice says the Hologic BioZorb marker is an implantable radiographic marker used to mark soft tissue, such as breast tissue, for future medical procedures such as radiation. Complaints about the markers have included reports of pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast and the need for additional medical treatment to remove the device. There have been 71 reported injuries, FDA says, and no reports of death.