OverStitch Suture Cinch — Class II medical device recall Z-2961-2026
Ongoing recall by Boston Scientific Corporation, reported 2026-08-26, distributed nationwide. Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
| Recall number | Z-2961-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boston Scientific Corporation, Marlborough, MA, United States |
| Recall initiated | 2026-07-14 |
| Classified | 2026-08-14 |
| Reported by FDA | 2026-08-26 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, BE, BG, CA, CH, CL, CR, CZ, DE, DK, DO, EG, ES, FI, FR, GB, GR, HK, HR, HU, IE, IL, IT, JP, LV, MT, NL, NO, PK, PL, PT, QA, RO, RS, SA, SE, SK, TH, TW |
| Quantity | 60,654 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00191506060046 |
| Lot numbers | 36159783, 36179248, 36179249, 36179250, 36179674, 36181153, 36193585, 36195262, 36195281, 36213130, 36213131, 36222433, 36223110, 36233350, 36233423, 36233424, 36238771, 36246477, 36247744, 36247745, 36257144, 36257145, 36264795, 36266604, 36285303, 36285304, 36291094, 36291142, 36296642, 36297718, 36298785, 36299374, 36307286, 36335098, 36336245, 36336246, 36336247, 36336248, 36336249, 36349543 and 182 more |
Product
OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.
Reason for recall
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
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-2961-2026. 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.