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.
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
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.
The markers can cause pain, infection, rash, or migration in the body. They may erode or move, leading to the need for additional medical treatment to remove them.
Women who received BioZorb markers during breast procedures are most at risk. The markers are used for radiographic marking of soft tissue sites in the breast.
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.
If you have pain, infection, rash, or device migration, contact your doctor immediately.
Your doctor can assess if the marker needs removal due to complications like pain or infection.
The recall is due to reported complications like pain, infection, and device migration. They are not safe without medical supervision.
Affected models include F0405, F0404, F0331, F0231, F0221, F0304, F0303, F0203, and F0202.
The recall does not require returning the marker. However, if complications occur, your doctor may need to remove it.
We’ve drafted a message you can send Hologic to request your refund or repair — edit it as you like.
Subject: Recall Z-1733-2024 — Hologic Hologic Hello, I own a Hologic that is covered by recall Z-1733-2024 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.
