Captivator Single-Use Polypectomy Snares — Class II medical device recall Z-1168-2021
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-1168-2021 |
|---|---|
| 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 | 08714729019251, 08714729019312, 08714729019336, 08714729019350, 08714729019411, 08714729019459, 08714729071068, 08714729501640, 08714729501657, 08714729747680, 08714729747833, 08714729747857, 08714729747871, 08714729747932, 08714729747956, 08714729747970, 08714729747994 |
| Lot numbers | 24709536, 24719202, 24725319, 24729758, 24732964, 24773287, 24780939, 24782687, 24782689, 24782693, 24782695, 24812577, 24842597, 24844193, 24882357, 24889755, 24889757, 24961643, 24961645, 24989260, 25010054, 25016793 |
Product
Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. Outer box UPN, Inner Pouch UPN: M00561311 (Box 10), M00561310 M00562301 (Box 10), M00562300; M00562321 (Box 10), M00562320; M00562341 (Box 10), M00562340; M00562451 (Box 10), M00562450; M00562401 (Box 10), M00562400; M00562402 (Box 40), M00562400; M00562422 (Box 40), M00562420; M00562471 (Box 10), M00562470.
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-1168-2021. 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.