Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

BioZorb Marker. Radiographic soft tissue marker. Recalled by Hologic, Inc Due to Firm received reports of adverse events/complications that include...

Date: October 10, 2024
Company: Hologic, Inc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Hologic, Inc directly.

Affected Products

BioZorb Marker. Radiographic soft tissue marker.

Quantity: 12,710 units

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Hologic, Inc

Hologic, Inc has 24 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report