SMART FLEX 6x120 BIL — Class II medical device recall Z-0217-2022
Ongoing recall by Cordis Corporation, reported 2021-11-24, distributed in CA, FL, IN, LA, OH, OK, TX. There is a potential for distal tip dislodgement or separation.
| Recall number | Z-0217-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Cordis Corporation, Miami Lakes, FL, United States |
| Recall initiated | 2021-10-01 |
| Classified | 2021-11-12 |
| Reported by FDA | 2021-11-24 |
| Distributed | CA, FL, IN, LA, OH, OK, TX |
| Countries outside the US | CA |
| Quantity | 3 units |
| Lot numbers | 266401 |
Product
SMART FLEX 6x120 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Reason for recall
There is a potential for distal tip dislodgement or separation.
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-0217-2022. 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.