Use caution Medical device recall · FDA · Published March 13, 2024

Hologic BioZorb Markers: Risk of Pain and Infection After Breast Procedures

Hologic recalls BioZorb 3D bioabsorbable markers used in breast procedures due to reported pain, infection, and device complications. Affected models include F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1733-2024Medical device Hologic ›

Use caution until it’s fixed

Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast, and the need for additional medical treatment to remove the device

Take action

Contact the company

Recalling firmHologic, Inc250 Campus Dr · Marlborough, MA 01752-3020

✎ GovInfoNow plain-language explainer

Hologic is recalling BioZorb 3D bioabsorbable markers used for breast procedures because they've caused pain, infections, and other complications. These markers can migrate or erode in the body, requiring additional medical treatment. Read more at govinfonow.com/recall/55888-hologic-biozorb-markers-risk-of-pain-and-infection-after-breast.

Source Summary by GovInfoNow · govinfonow.com/recall/55888-hologic-biozorb-markers-risk-of-pain-and-infection-after-breast · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1733-2024

Cite this page

“Hologic BioZorb Markers: Risk of Pain and Infection After Breast Procedures.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/55888-hologic-biozorb-markers-risk-of-pain-and-infection-after-breast. Based on FDA recall #Z-1733-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1733-2024%22&limit=1).

The FDA announced on March 13, 2024, that Hologic, Inc. is recalling BioZorb Marker devices due to safety complaints involving pain, infection, and device migration. The agency classified the recall as Class I.

How to tell if you have it

Brand: Hologic
Product: BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue
Model F0405: BioZorb Marker 4cm x 5cm
Model F0404: BioZorb Marker 4cm x 4cm
Model F0331: BioZorb Marker 1cm x 3cm x 3cm
Model F0231: BioZorb Marker 1cm x 3cm x 2cm
Model F0221: BioZorb Marker 1cm x 3cm x 2cm
Model F0304: BioZorb Marker 3cm x 4cm
Model F0303: BioZorb Marker 3cm x 3cm
Model F0203: BioZorb Marker 2cm x 3cm
Model F0202: BioZorb Marker 2cm x 2cm
UDI-DI: 15420045514065, 15420045514058, 15420045514041, 15420045514034, 15420045514027, 15420045514010, 15420045514003, 15420045513990, 15420045513983
Distribution: US Nationwide Distribution
Units affected: 53492

The hazard

Complaints describe complications that include pain, infection, rash, device migration, device erosion, seroma, discomfort, or other complications from feeling the device in the breast. These issues have led to the need for additional medical treatment to remove the device.

Context

GovInfoNow's records show Hologic, Inc has 30 other recalls on record since 2017-06-27. Recent brand recalls include a 2026-04-08 recall of Hologic 3D Mammography Systems for loose bolts risk and a 2026-03-23 recall of the Hologic Genius Review Station Display for user modifications risk. Other recent recalls of similar products include HydroMARK Breast Biopsy Marker Recall (2026-04-24) and Bard Breast Biopsy System May Cause Procedure Interruptions - Recall 2026 (2026-08-20).

How to tell if you have this one

Check for BioZorb markers labeled with model numbers F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, or F0202. The markers are 1-5 cm in size and used for breast procedures.

Brand
Hologic
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check for Complications
If you have pain, infection, rash, or device migration, contact your doctor immediately.
Contact Your Doctor
Your doctor can assess if the marker needs removal due to complications like pain or infection.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 2 months after the firm started it.

Mar 13, 2024Firm started the recall
May 3, 2024FDA classified it Class I
May 15, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Do I need to return the marker?

The recall does not require returning the marker. However, if complications occur, your doctor may need to remove it.

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Link to this recall

<a href="https://govinfonow.com/recall/55888-hologic-biozorb-markers-risk-of-pain-and-infection-after-breast">Hologic BioZorb Markers: Risk of Pain and Infection After Breast Procedures (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1733-2024 (March 13, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1733-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.