Optima Coil System Model Number OPTI0208CSS10 — Class II medical device recall Z-0103-2023
Ongoing recall by BALT USA, LLC, reported 2022-10-26, distributed nationwide. Product pouch label does not match up with carton label
| Recall number | Z-0103-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | BALT USA, LLC, Irvine, CA, United States |
| Recall initiated | 2022-09-07 |
| Classified | 2022-10-20 |
| Reported by FDA | 2022-10-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | DO, IN, JP |
| Quantity | 41 impacted |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00818053025815, 00818053025891 |
| Lot numbers | F220601068, F220601089 |
| Model numbers | OPTI0208CSS10, OPTI0308CSS10 |
Product
Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures.
Reason for recall
Product pouch label does not match up with carton label
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-0103-2023. 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.