Hologic, Inc recalls BioZorb Marker. Radiographic soft tissue marker.

Recall date

October 10, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0328-2025

FDA classification

Class I

Brand / firm

Hologic, Inc

Sold / distributed

Domestic: US Nationwide Distribution.

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

BioZorb Marker. Radiographic soft tissue marker.