Fixed Core Wire Guide — Class II medical device recall Z-1833-2022
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-1833-2022 |
|---|---|
| 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 | 00827002004122, 00827002004412, 00827002004559, 00827002004566, 00827002004665, 00827002004719, 00827002005075, 00827002005099, 00827002005112, 00827002005297, 00827002005525, 00827002009028, 00827002011519, 00827002016026, 00827002017931, 00827002020504, 00827002021600, 00827002021808, 00827002023840, 00827002026599, 00827002040694, 00827002069732 |
| Lot numbers | 14-06-2027, 14-07-2027, 14769750, 14774744, 14793143, 14793144, 14795051, 14795053, 14795058, 14795071, 14795155, 14795156, 14795157, 14797500, 14797503, 14798672, 14798678, 14802358, 14803096, 14803099, 14803101, 14803102, 14803184, 14805743, 14805744, 14805745, 14807601, 14808542, 14808543, 14808544, 14808547, 14808548, 14811921, 14811922, 14811923, 14811924, 14811925, 14813705, 14813712, 14814967 and 104 more |
| Model numbers | C-SCF-15-30-2, C-SCF-18-40-2, C-SCF-18-50-3, C-SCF-25-50-3, G00412, G00441, G00455, G00456, G00466, G00471, G00507, G00509, G00511, G00529, G00552, G00902, G01151, G01602, G01793, G02050, G02160, G02180, G02384, G02659, G04069 and 19 more |
Product
Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507 TSCF-35-145-3 G00511 TSCF-38-80-3 G00552 TSCF-18-180-3 G02160 TSCF-35-80-3 G00529 TSCF-21-180-3 G01793 TSCF-25-260-3 G00471 C-SCF-18-50-3 G02050 C-SCF-18-40-2 G02659 C-SCF-25-50-3 G02180 TSCF-18-80-3 G00441 C-SCF-15-30-2 G06973
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-1833-2022. 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.