Class II — Cook Incorporated
| Recalling firm | COOK, INC. |
|---|---|
| Registered facility | View this company's 5 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Devices from the affected device lots have labels that state the incorrect expiration dates. |
| Product | Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 |
| Quantity | 10 units |
| Distribution | International Distribution to: Korea only |
| Initiated | 2024-10-14 |
| Classified | 2024-11-21 |
| Recall number | Z-0499-2025 |
| 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 — Cook Incorporated (Z-0499-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95582/
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