Captivator II Single-Use Polypectomy Snares Outer box UPN — Class II medical device recall Z-1169-2021
Ongoing recall by Boston Scientific Corporation, reported 2021-03-10, distributed nationwide. Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
| Recall number | Z-1169-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2021-01-19 |
| Classified | 2021-03-04 |
| Reported by FDA | 2021-03-10 |
| Distributed | Nationwide (US) |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 08714729855903, 08714729855934, 08714729861263, 08714729861294, 08714729861300, 08714729861317, 08714729861324, 08714729861348 |
| Lot numbers | 24665104, 24670592, 24676929, 24679614, 24679619, 24770325, 24772995, 24939628, 24948407, 24952552, 25053639, 25054403 |
Product
Captivator II Single-Use Polypectomy Snares Outer box UPN, Inner Pouch UPN: M00561191 (Box 10), M00561190; M00561221 (Box 10), M00561220; M00561222 (Box 20), M00561220; M00561223 (Box 40), M00561220; M00561233 (Box 40), M00561230.
Reason for recall
Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.
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-1169-2021. 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.