FDA Device recall Z-2962-2026
Suture Cinch Long 1pk
- FDA Device
- Class II
- ongoing
- Published 2026-08-26
On 2026-08-26 the FDA classified a Class II recall of Suture Cinch Long 1pk by Boston Scientific, citing device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2962-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-14 |
| Published | 2026-08-26 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Boston Scientific |
| Distribution | US |
Product
Suture Cinch Long 1pk. Endoscopic tissue approximation device.
Reason
Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.
Identifiers
| code_info | Material No. M00505550; GTIN: 00191506049188; Lot No. 35903543, 35948104, 35948105, 35976434, 35976435, 35976436, 36023…Material No. M00505550; GTIN: 00191506049188; Lot No. 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, 37019868, 37031959, 37073352, 37086263, 37096406, 37108084, 37116726, 37124788, 37126750, 37128111, 37302211, 37399016, 37533710, 37586915, 37604205, 37663465, 38587149,38598199, 38823176, 38833088, 39053113, 39091844; Exp. Date Range: 26-Feb-2028 to 14-Apr-2029. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Device · Class II · 2026-09-09 · Boston Scientific
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2962-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.