Cordis S — Class II medical device recall Z-0324-2018
Terminated recall by Cordis Corporation, reported 2018-01-17, distributed nationwide. Potential for cracked luer hubs
| Recall number | Z-0324-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2017-11-15 |
| Classified | 2018-01-09 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2019-11-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 511 |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 20705032065570, 20705032065600, 20705032065617, 20705032065648, 20705032065655, 20705032065662, 20705032065723, 20705032065747, 20705032065778, 20705032065938, 20705032065945, 20705032066034, 20705032066072, 20705032066089, 20705032066096, 20705032066164, 20705032066171, 20705032066263, 20705032066317, 20705032066348 |
| Lot numbers | 40996, 40997, 40998, 40999, 41002, 41003, 41004, 41055, 41056, 41058, 41122, 41124, 41198, 41199, 41200, 41202, 41203, 41316, 41318, 41319, 41320, 41322, 41323, 41352, 41353, 41354, 41355, 41356, 41359, SF05100MB, SF06100MB, SF06120MB, SF06150MB, SF07080MB, SF07100MB, SF07150MB, SF08100MB, SF08120MB, SF09030MB, SF09030SB and 9 more |
| Model numbers | 20705032065570, 20705032065600, 20705032065617, 20705032065648, 20705032065655, 20705032065662, 20705032065723, 20705032065747, 20705032065778, 20705032065938, 20705032065945, 20705032066034, 20705032066072, 20705032066089, 20705032066096, 20705032066164, 20705032066171, 20705032066263, 20705032066317, 20705032066348, 40996, 40997, 40998, 40999, 41002 and 44 more |
Product
Cordis S.M.A.R.T. Flex Biliary Stent System Product Usage: Is indicated for use in the palliation of malignant strictures in the biliary tree.
Reason for recall
Potential for cracked luer hubs
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-0324-2018. 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.