Class II — Oscor Inc.
| Recalling firm | OSCOR INC. |
|---|---|
| Registered facility | OSCOR INC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Completed |
| Reason | There is potential for separation between the threaded hub and threaded cap at the proximal end of the device. |
| Product | Destino Twist 14F (also branded as Guidestar 14F) |
| Quantity | 549 units |
| Distribution | Distribution to TN and PA in USA OUS distribution to Czech Republic |
| Initiated | 2021-12-22 |
| Classified | 2022-02-17 |
| Recall number | Z-0646-2022 |
| 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 — Oscor Inc. (Z-0646-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/89392/
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