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.
Hologic is recalling BioZorb Marker radiographic soft tissue markers because they've caused serious injuries including pain, infection, and device migration. This affects specific model numbers and lot numbers listed in the recall.
The markers can cause serious injuries such as pain, infection, rash, device migration, erosion, seroma, and discomfort when used in soft tissue. These complications occur due to the marker's material interacting with the body.
Medical professionals who use these markers for radiographic imaging are most at risk. Patients who received the recalled markers may also experience complications.
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.
Look for model numbers F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, or F0202 on the marker.
Reach out to Hologic directly for assistance with the recall or to report concerns about the marker.
The recall reports serious injuries including pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Affected models include F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, and F0202.
Check the model number on the marker or the lot number listed in the recall notice.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-0328-2025 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-0328-2025 from Hologic. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
