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 | 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. |
| Product | Optima Coil System Model OPTI0520CSF10. For endovascular embolization. |
| Quantity | 4 devices |
| Distribution | U.S.: AZ and FL O.U.S.: None |
| Initiated | 2022-07-26 |
| Classified | 2022-09-06 |
| Recall number | Z-1680-2022 |
| 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-1680-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90724/
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