BioZorb Marker — Class I medical device recall Z-0328-2025
Ongoing recall by Hologic, Inc, reported 2024-12-04, distributed nationwide. Firm received reports of adverse events/complications that include serious injuries, such as pain, infection,
| Recall number | Z-0328-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2024-10-10 |
| Classified | 2024-11-26 |
| Reported by FDA | 2024-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 12,710 units |
| UPC / GTIN / UDI-DI | 15420045513983, 15420045513990, 15420045514003, 15420045514010, 15420045514027, 15420045514034, 15420045514041, 15420045514058, 15420045514065 |
| Lot numbers | 22D20RV, 22D21RAA, 22D21RBB, 22D21RX, 22D21RY, 22D21RZ, 22E20RAA, 22E20RZ, 22E24R, 22E24RA, 22E24RB, 22E24RG, 22E24RH, 22F06RK, 22F06RL, 22F16RV, 22F21R, 22F25RD, 22F25RF, 22F29RJ, 22F29RK, 22G21RL, 22G21RM, 22G26RL, 22G26RM, 22G26RN, 22G26RP, 22G26RQ, 22H20R, 22H22RS, 22H22RT, 22H24RK, 22H24RL, 22H24RM, 22J22RAA, 22J22RBB, 22J26RC, 22J26RD, 22J26RF, 22J26RG and 85 more |
| Model numbers | F0202, F0203, F0221, F0231, F0303, F0304, F0331, F0404, F0405 |
Product
BioZorb Marker. Radiographic soft tissue marker.
Reason for recall
Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma, and discomfort.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0328-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.