Flexor Check-Flo Introducers and Sets — Class II medical device recall Z-0993-2026
Ongoing recall by Cook Incorporated, reported 2025-12-31. Cook Medical identified that products supplied in the affected device lots may have been manufactured out of s
| Recall number | Z-0993-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cook Incorporated, Bloomington, IN, United States |
| Recall initiated | 2025-11-26 |
| Classified | 2025-12-23 |
| Reported by FDA | 2025-12-31 |
| Quantity | 7,952 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00827002094420, 00827002126060, 00827002130319, 00827002130326, 00827002130333, 00827002130814, 00827002131606, 00827002322332, 00827002323735, 00827002363939, 00827002477001, 00827002477018, 00827002491014, 00827002491021, 00827002494879, 00827002562783, 00827002562790 |
| Lot numbers | 16602829, 16607912, 16607936, 16607937, 16607958, 16613273, 16614607, 16614610, 16614616, 16614624, 16614632, 16614648, 16616270, 16618070, 16621277, 16621278, 16621284, 16621305, 16623383, 16627324, 16629368, 16632466, 16632469, 16632678, 16635746, 16635801, 16637278, 16637282, 16637284, 16637317, 16638956, 16638969, 16638970, 16638978, 16641423, 16643080, 16643081, 16644768, 16647072, 16647073 and 71 more |
Product
Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0-18/38-45-RB-ANL0-HC; 2) KCFW-9.0-18/38-45-RB-ANL1-HC; 3) KCFW-10.0-35-45-RB-HFANL0-HC; 4) KCFW-10.0-35-45-RB-HFANL1-HC; 5) KCFW-12.0-35-45-RB-HFANL0-HC; 6) KCFW-12.0-35-45-RB-HFANL1-HC; 7) KCFW-9.0-35-38.5-RB-RTPS-100; 8) KCFW-10.0-35-RB-RTPS-100; 9) KCFW-9.0-38-55-RB-RAABE; 10) KCFW-9.0-38-70-RB-RAABE; 11) KCFW-9.0-38-80-RB; 12) KCFW-10.0-38-30-RB; 13) KCFW-10.0-38-40-RB; 14) KCFW-10.0-38-80-RB; 15) KCFW-10.0-38-RB; 16) KCFW-12.0-38-40-RB; 17) KCFW-12.0-38-80-RB; Flexor Introducers and Guiding Sheaths are designed to perform as a guiding sheath and/or introducer sheath. Flexor Introducers and Guiding Sheaths incorporate a Flexor shaft with a hemostasis valve and are provided with one or more dilators. These devices are available in various sizes, lengths and configurations. Configurations include differences in shaft construction, such as varying shaft stiffness and distal tip material and shape, dilator material, hydrophilic coating and/or distal radiopaque markers.
Reason for recall
Cook Medical identified that products supplied in the affected device lots may have been manufactured out of specification. Impacted products may have been cut to the incorrect length, not correctly trimmed, and not inspected properly.
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-0993-2026. 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.