Suture Cinch Long 1pk — Class II medical device recall Z-2962-2026
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-2962-2026 |
|---|---|
| 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 | 00191506049188 |
| Lot numbers | 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023412, 36054695, 36083619, 36116489, 36124315, 36138740, 36222818, 36222819, 36222960, 36231427, 36232903, 36238318, 36291083, 36298791, 36346089, 36346101, 36376494, 36390167, 36411916, 36428532, 36432020, 36443931, 36444025, 36453238, 36472920, 36472938, 36618380, 36624306, 36634952, 36646601, 36724691, 36846026, 36855626, 37019759 and 22 more |
Product
Suture Cinch Long 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-2962-2026. 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.