Class II — BALT USA, LLC
| Recalling firm | Balt USA, LLC |
|---|---|
| Registered facility | BALT USA, LLC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Product pouch label does not match up with carton label |
| Product | Optima Coil System Model Number OPTI0208CSS10, Model Number OPTI0308CSS10. Used in endovascular procedures. |
| Quantity | 41 impacted devices |
| Distribution | Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan. |
| Initiated | 2022-09-07 |
| Classified | 2022-10-20 |
| Recall number | Z-0103-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — BALT USA, LLC (Z-0103-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90870/
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