Cope Mandril Wire Guide — Class II medical device recall Z-1830-2022
Ongoing recall by Cook Incorporated, reported 2022-10-05, distributed nationwide. Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron s
| Recall number | Z-1830-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2022-08-16 |
| Classified | 2022-09-28 |
| Reported by FDA | 2022-10-05 |
| Distributed | Nationwide (US) |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00827002051836, 00827002058224, 00827002100770 |
| Lot numbers | 14-07-2027, 14795012, 14797819, 14801636, 14804264, 14804265, 14806984, 14806985, 14809295, 14809296, 14815841, 14815842, 14815852, 14815853, 14815854, 14819080, 14819081, 14831205, 14831206, 14841236, 15-06-2027, 16-06-2027, 20-06-2027, 21-06-2027, 22-06-2027, 23-06-2027, 27-06-2027, 29-06-2027, G05822, G10077, PMG-18SP-100-COPE, PMG-18SP-125-COPE |
| Model numbers | G05183, G05822, G10077, PMG-18SP-100-COPE, PMG-18SP-125-COPE, PMG-18SP-60-COPE |
Product
Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
Reason for recall
Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
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-1830-2022. 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.