{"url_path":"/fda/device/recalls/Z-2962-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — Suture Cinch   Long 1pk. \tEndoscopic tissue approximation device.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-07-14","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2962-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Boston Scientific Corporation"},"word_count":189,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2962-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-07-14\n**Report date:** 2026-08-26\n\n## Product\nSuture Cinch   Long 1pk. \tEndoscopic tissue approximation device.\n\n## Reason\nDevice may fail to deploy the cinch implant and/or fail to cut the suture as intended.\n\n## Affected lots\nMaterial 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.\n\n## Distribution\nWorldwide distribution - US Nationwide and the countries of Austria, Azerbaijan, Belgium, Bulgaria, Canada, Chile, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Latvia, Malta, Netherlands, Norway, Pakistan, Poland, Portugal, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, UAE, United Kingdom."}