Check=Flo Performer Introducer — Class II medical device recall Z-1787-2025
Ongoing recall by Cook Incorporated, reported 2025-05-28, distributed nationwide. Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introduce
| Recall number | Z-1787-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2025-04-17 |
| Classified | 2025-05-16 |
| Reported by FDA | 2025-05-28 |
| Distributed | Nationwide (US) |
| Countries outside the US | BE, CH, DE, ES, FR, IE, IT, NL, SI, ZA |
| Quantity | 89 units |
| UPC / GTIN / UDI-DI | 00827002089570 |
| Lot numbers | 16376242 |
| Model numbers | G08957, RCFW-14.0-0-38-30-RB |
Product
Check=Flo Performer Introducer, 14.0Fr, Reference Part Number(RPN) REF RCFW-14.0-0-38-30-RB, Order Number (GPN) REF G08957,
Reason for recall
Cook Medical identified that devices from the affected device lots may contain the incorrectly sized introducer sheath.
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-1787-2025. 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.