Optima Coil System Model OPTI0520CSF10 — Class II medical device recall Z-1680-2022
Ongoing recall by BALT USA, LLC, reported 2022-09-14, distributed in AZ, FL. Products were released to customers prior to the approval and release of a test report authorizing the use of
| Recall number | Z-1680-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BALT USA, LLC, Irvine, CA, United States |
| Recall initiated | 2022-07-26 |
| Classified | 2022-09-06 |
| Reported by FDA | 2022-09-14 |
| Distributed | AZ, FL |
| Quantity | 4 devices |
| UPC / GTIN / UDI-DI | 00818053026164 |
| Lot numbers | F220600470 |
| Model numbers | OPTI0520CSF10 |
Product
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Reason for recall
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
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-1680-2022. 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.