{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "220308", "product_res_number": "Z-2413-2026", "event_date_initiated": "2026-05-12", "event_date_posted": "2026-06-11", "recall_status": "Open, Classified", "res_event_number": "98970", "product_code": "ODC", "k_numbers": [ "K252910" ], "product_description": "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.", "code_info": "GTIN 00840253111012, Lot 38400303, Exp. January 20, 2029", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Renee Archie\n508-683-4523", "reason_for_recall": "Boston 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.", "root_cause_description": "Process control", "action": "Boston Scientific issued an Urgent Medical Device Removal - Immediate Action Required notice to its consignees on 5/12/2026 via FedEx. The notice explained the issue with the device, potential risk to the patient, and requested the following: \nActions\n\" Immediately stop further use or distribution and segregate affected product. \n\" Complete and return the enclosed Reply Verification Tracking Form per the included instructions. \n\" Return product to Boston Scientific in accordance with the enclosed instructions. \n\" Share this communication with any healthcare professionals in your hospital that use\nthe product and with any other organization to which these systems may have been transferred. \nFor additional assistance or more information regarding this communication, please contact your local Boston Scientific representative.", "product_quantity": "9750 units", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K110291", "K232118", "K093329", "K151714", "K252933", "K160403", "K111760", "K110088", "K010610", "K232244", "K213095", "K102581", "K181712", "K202104", "K090851", "K240098", "K252910", "K101094", "K211814", "K221331", "K162142", "K112698", "K232249", "K192059", "K200495", "K222499", "K862107", "K024301", "K884097", "K080764", "K210342", "K232327", "K173105", "K190164", "K220247", "K220884", "K250732", "K210353", "K915719", "K200481", "K213483", "K191231", "K202237", "K242742", "K250949", "K210625", "K240352", "K800962", "K200769", "K232951", "K073484", "K192258", "K241285", "K151345", "K920030", "K192048", "K241842", "K220210", "K232004", "K232329", "K203630", "K102409", "K232067", "K250140", "K222980", "K243075", "K250145", "K073507", "K112106", "K221264", "K103155", "K970110" ], "registration_number": [ "3002808022", "3008058134", "1820334", "2124215", "9611102", "3003207991", "3022106566", "2528981", "9614279", "2024311", "3015970743", "3026121953", "3011050570", "3017262662", "3028058843", "1418479", "1828132", "2032098", "3010288205", "3003903031", "3010273872", "3010400865", "3004837686", "1650907", "3021023752", "2518897", "3032578846", "3008797804", "3010408671", "8010047", "3002807314", "3044707938", "1000393132", "1825146", "1651395", "3010612620", "3005099803", "3005580113", "3009763019", "3009064553", "3025347444", "3021349683", "9610877", "3020707080", "3000974800", "1047843", "3005261802", "1320894", "9610595", "3003790304", "3003782610", "3007789561", "3032507796", "1423662", "3017968993", "3006787036", "3013440400", "2183446", "3011707784", "1037905", "3002808148", "2027111", "3006621103", "3011193403", "3013023255", "2246552", "3013460719", "9616684", "3008048800", "3009051888", "3004111573", "9681260", "3010230734", "3008573567", "1000121056", "1528319", "3017911818", "3018116884", "3014749926" ], "fei_number": [ "3002808022", "3008058134", "1820334", "2124215", "3003207991", "3003767881", "3022106566", "2528981", "2024311", "3015970743", "3026121953", "3011050570", "3017262662", "3028058843", "1418479", "1828132", "3003012447", "3010288205", "3002964398", "3003903031", "3010273872", "3010400865", "3004837686", "3021023752", "3032578846", "3008797804", "3010408671", "3002807314", "3044707938", "1000393132", "1825146", "3008185830", "3010612620", "3005099803", "3002808001", "3005580113", "3009763019", "3009064553", "1000080301", "3025347444", "3021349683", "3002913962", "1000122656", "3020707080", "3000974800", "1047843", "3005261802", "3003790304", "3003782610", "3007789561", "3032507796", "3002807795", "3017968993", "3006787036", "3013440400", "2183446", "3002681132", "3011707784", "1037905", "3001451571", "3002806565", "3002808148", "2027111", "3006621103", "3011193403", "3013023255", "2246552", "3013460719", "3008048800", "3000215273", "3009051888", "3004111573", "3003058448", "3010230734", "3008573567", "1000121056", "3017911818", "3018116884", "3014749926" ], "device_name": "Endoscope Channel Accessory", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }