Class II — Boston Scientific Corporation
| Recalling firm | Boston Scientific Corporation |
|---|---|
| Registered facility | View this company's 37 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The sterile barrier may contain packaging seal defects. |
| Product | Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210 |
| Quantity | 18 units |
| Distribution | The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain. |
| Initiated | 2018-12-26 |
| Classified | 2019-03-14 |
| Terminated | 2020-04-17 |
| Recall number | Z-1013-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Boston Scientific Corporation (Z-1013-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82068/
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