BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use… — Class I medical device recall Z-1733-2024
Ongoing recall by Hologic, Inc, reported 2024-05-15, distributed nationwide. Safety Information: Complaints describe complications/adverse events that include pain, infection, rash, devic
| Recall number | Z-1733-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2024-03-13 |
| Classified | 2024-05-03 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 53,492 |
| UPC / GTIN / UDI-DI | 15420045513983, 15420045513990, 15420045514003, 15420045514010, 15420045514027, 15420045514034, 15420045514041, 15420045514058, 15420045514065 |
Product
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1cm x 3cm x 3cm 4) F0231 BioZorb Marker 1cm x 3cm x 2cm 5) F0221 BioZorb Marker 1cm x 3cm x 2cm 6) F0304 BioZorb Marker 3cm x 4cm 7) F0303 BioZorb Marker 3cm x 3cm 8) F0203 BioZorb Marker 2cm x 3cm 9) F0202 BioZorb Marker 2cm x 2cm
Reason for recall
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
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-1733-2024. 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.