Hologic Recalls Soft Tissue Marker Device BioZorb, FDA Issues Warning After Almost 400 Complaints

On Friday, the FDA warned against using Hologic Inc.’s (NASDAQ:HOLX) BioZorb Marker products and urged healthcare facilities to return all unused lots.

This follows Hologic’s voluntary recall of the BioZorb Marker and BioZorb LP Marker, implantable devices intended for marking sites in soft tissues like breast tissue.

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The recall comes in response to reports of serious adverse events in patients, including pain, infection, and device migration, among others.

The BioZorb ...