Flexima Duodenal Bend Biliary Stent with Delivery System — Class II medical device recall Z-1012-2019
Terminated recall by Boston Scientific Corporation, reported 2019-03-20, distributed in AL, CA, IL, MD, PA, TN, TX, UT…. The sterile barrier may contain packaging seal defects.
| Recall number | Z-1012-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2018-12-26 |
| Classified | 2019-03-14 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2020-04-17 |
| Distributed | AL, CA, IL, MD, PA, TN, TX, UT, WI |
| Countries outside the US | AT, DE, EC, ES, IT, PT, RO, SA |
| Quantity | 75 units |
| Reason classes | sterility, packaging |
| Lot numbers | 22960202 |
Product
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x10cm, Material Number M00539220
Reason for recall
The sterile barrier may contain packaging seal defects.
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-1012-2019. 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.