{"url_path":"/fda/device/recalls/Z-2413-2026","section_key":"summary","section_title":"DEVICE Recall: Boston Scientific Corporation — Orca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-12","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2413-2026%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":107,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2413-2026\n\n**Recalling firm:** Boston Scientific Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-12\n**Report date:** 2026-06-17\n\n## Product\nOrca Single Use Air/Water and Suction Valves, Material Number (UPN) SUV-617-50; The Orca Air/Water Valve is intended to be used to control the air/water function on an endoscope during a GI (gastrointestinal) endoscopic procedure.\n\n## Reason\nBoston Scientific is initiating a medical device removal of  Orca Sterile, Single Use Air/Water and Suction Valves due to a higher than anticipated occurrence of the suction button sticking.\n\n## Affected lots\nGTIN 00840253111012, Lot 38400303, Exp. January 20, 2029\n\n## Distribution\nUS Nationwide distribution."}