Class I

Medical Device Recall: BioZorb Marker. Radiographic soft tissue marker.

Hologic, Inc · October 10, 2024

Reason for Recall

Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.

Distribution

Domestic: US Nationwide Distribution.

States Affected

NATIONWIDE

Quantity Affected

12,710 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0328-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Hologic, Inc Medical Device Recall: BioZorb Marker. Radiographic soft tissue marker. | SafeCheck