Approach CTO Micro Wire Guide — Class II medical device recall Z-0346-2025
Ongoing recall by Cook Incorporated, reported 2024-11-20, distributed nationwide. Affected device lots have labels that state the incorrect expiration dates.
| Recall number | Z-0346-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2024-10-08 |
| Classified | 2024-11-08 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00827002507869, 00827002507876, 00827002507883, 00827002507890, 00827002507906, 00827002507913, 00827002507920, 00827002507937 |
| Lot numbers | 15718980, 15718981, 15718982, 15731211, 15763552, 15763553, 15763561, 15763563, 15763571, 15763577, 15763579, 15763580, 15763585, 15763591, 15763597, 15763604, 15763605, 15763609, 15765959, 15765960, 15769462, 15773059, 15778251, 15778254, 15783003, 15791923, 15794895, 15794896, 15794897, 15794898, 15800156, 15800162, 15802924, 15802926, 15802931, 15802931X, 15802932, 15802933, 15811660, 15811662 and 79 more |
| Model numbers | CMW-14-190-12G, CMW-14-190-18G, CMW-14-190-25G, CMW-14-190-6G, CMW-14-300-12G, CMW-14-300-18G, CMW-14-300-25G, CMW-14-300-6G |
Product
Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Reason for recall
Affected device lots have labels that state the incorrect expiration dates.
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-0346-2025. 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.