FDA Recall Roundup: October 2024

Hologic BioZorb Marker

Hologic announced the voluntary recall of all unused lots of BioZorb markers and BioZorb LP markers due to reports of serious adverse events (AEs) occurring in patients who had the product implanted in breast tissue.

Reported complications and AEs associated with using the marker in breast tissue include pain, infection, rash, device migration, device erosion, seroma, discomfort, and complications from feeling the device in the breast. Additionally, in some instances, additional medical treatment like having to have the device removed was needed, according to the company.