The BioZorb LP Marker is an implantable radiopaque marker used to… — Class II medical device recall Z-1858-2022
Ongoing recall by Hologic, Inc, reported 2022-10-12, distributed nationwide. Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expir
| Recall number | Z-1858-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hologic, Inc, Marlborough, MA, United States |
| Recall initiated | 2022-08-09 |
| Classified | 2022-09-30 |
| Reported by FDA | 2022-10-12 |
| Distributed | Nationwide (US) |
| Quantity | 233 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 15420045514027 |
| Lot numbers | 22A0RL |
| Expiration dates | 2022-01-20, 2024-07-08 |
Product
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component which resorbs completely in 1 year or more and a permanent component (titanium). The BioZorb LP Marker is provided sterile for single use and is implantable.
Reason for recall
Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an expiration date that indicated the product had already expired. The expiration date on the removable label is actually manufacturing date, and it's different from the one on the shelf box label, which is the correct expiration date.
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-1858-2022. 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.