Hologic recalls BioZorb Marker radiographic soft tissue markers due to serious injuries like pain, infection, and device migration. Affected models include F0405, F0404, and others. Contact Hologic for details.
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Take action
Contact the company
📍Recalling firmHologic, Inc250 Campus Dr · Marlborough, MA 01752-3020
“Hologic BioZorb Marker Recall: Serious injury risks with soft tissue markers.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53728-hologic-biozorb-marker-recall-serious-injury-risks-with-soft-tissue. Based on FDA recall #Z-0328-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0328-2025%22&limit=1).
The FDA announced on Oct. 10, 2024, that Hologic, Inc. is recalling BioZorb radiographic soft tissue markers due to reports of serious injuries including pain, infection, and device migration. The voluntary Class I recall affects 12,710 units distributed nationwide.
The FDA said the firm received reports of adverse events and complications including serious injuries such as pain, infection, rash, device migration, device erosion, seroma, and discomfort. GovInfoNow's records show no specific incident counts were provided in this recall record.
Context
GovInfoNow's records show Hologic, Inc. has 30 other recalls on file since June 27, 2017. Recent Hologic recalls include the April 8, 2026, 3D Mammography Systems Recall for loose bolts risk and the March 23, 2026, Genius Review Station Display Recall for user modification safety risks. Other recent recalls of similar products include the HydroMARK Breast Biopsy Marker Recall (April 24, 2026), the Medtronic Bio-Medicus Adult Cannula Kit Recall (May 25, 2026), and the Biomet Intramedullary Bone Saw Blade Recall (July 1, 2026).
How to tell if you have this one
Check for model numbers F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, F0202 or lot numbers listed in the recall. The markers are radiographic soft tissue markers used in medical imaging.
Brand
Hologic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Model Number
Look for model numbers F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, or F0202 on the marker.
Contact Hologic
Reach out to Hologic directly for assistance with the recall or to report concerns about the marker.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Domestic: 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 55 days after the firm started it.
1Firm started the recall
2FDA classified it Class I
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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-0328-2025 (October 10, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0328-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.