{ "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": "2026-09-03", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "221549", "product_res_number": "Z-2961-2026", "event_date_initiated": "2026-07-14", "event_date_posted": "2026-08-14", "recall_status": "Open, Classified", "res_event_number": "99435", "product_code": "OCW", "k_numbers": [ "K181141", "K201808" ], "product_description": "OverStitch Suture Cinch, 1pk. Endoscopic tissue approximation device.", "code_info": "Material No. M00505530; GTIN: 00191506060046; Lot No. 36159783, 36179248, 36179249,\n36179250, 36179674, 36181153, 36193585, 36195262, 36195281,36213130, 36213131, 36222433, 36223110, 36233350, 36233423, 36233424, 36238771, 36246477, 36247744, 36247745, 36257144, 36257145, 36264795, 36266604, 36285303, 36285304, 36291094,\n36291142, 36296642, 36297718, 36298785, 36299374, 36307286, 36335098, 36336245, 36336246, 36336247, 36336248, 36336249, 36349543, 36358240, 36366410, 36368880, 36370038, 36376493, 36390716, 36400755, 36413832, 36429438, 36440653, 36440659, 36440798, 36441070, 36441390, 36443933, 36450076, 36451398, 36452061, 36454608, 36454861, 36461432, 36466525, 36472307, 36472448, 36472813, 36473087, 36475081, 36482317, 36482413, 36482837, 36482838, 36486869, 36488822, 36496658, 36498004, 36500343, 36500745, 36508877, 36509436, 36511012, 36519283, 36519622, 36564120, 36567088, 36567089, 36651483, 36651990, 36660007, 36670672, 36689082, 36691535, 36691536, 36692473, 36715146, 36715947, 36722429, 36733894, 36736063, 36737026, 36742475, 36747253, 36754086, 36756476, 36767158, 36770136, 36795290, 36802913, 36816032, 36816864, 36819466, 36829515, 36837613, 36840422, 36855429, 36859432, 36870323, 36884519, 36886399, 36887192, 36894183, 36906859, 37049911, 37053262,\n37063221, 37071091, 37082225, 37256930, 37258435, 37265997, 37268058, 37276648, 37277853, 37332709, 37335148, 37341879, 37431423, 37462817, 37475144, 37479080, 37512600, 37516705, 37538409, 37614916, 37628854, 37701281, 37712590, 37747392,\n37759135, 37768422, 37780435, 37804241, 37813732, 37824328, 37846636, 37861753, 37874884, 37906665, 37952534, 37976914, 37980916, 37987576, 38001581, 38020339, 38045267, 38055953, 38064514, 38087625, 38092029, 38119620, 38134479, 38149599, 38168976, 38265895, 38274202, 38277823, 38298897, 38307807, 38355532, 38404637, 38421970, 38438020, 38441891, 38448572, 38458999, 38480821, 38495024, 38498977, 38505659, 38526386, 38527090, 38540408, 38613546, 38620724, 38629370, 38672064, 38682255, 38692722, 38709195, 38711985, 38728857, 38738005, 38748320, 38759951, 38771565, 38787506, 38798542, 38808911, 38847193, 38866237, 38886764, 38917596, 38926776, 38936218, 38939941, 38948809, 39018825, 39029561, 39032429, 39043147, 39095582, 39114250, 39131778; Exp. Dat Range 25-Mar-2028 to 19-Apr-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\n508-683-4253", "reason_for_recall": "Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.", "root_cause_description": "Under Investigation by firm", "action": "An Urgent Medical Device Removal notification dated 7/14/26 was mailed to consignees instructing them to immediately stop further use or distribution of affected devices. Consignees are to forward the notice to relevant personnel and to facilities where product was further distributed. Healthcare personnel are to monitor patients that received care with affected devices per the standard of care. The provided response form is to be completed and returned to Boston Scientific, and product returned in accordance with the provided instructions. Consignees with any quality concerns can email BSCComplaints@bsci.com.", "product_quantity": "60,654 units", "distribution_pattern": "Worldwide 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.", "openfda": { "k_number": [ "K971939", "K994087", "K101101", "K062244", "K091832", "K193652", "K022229", "K103412", "K062875", "K961390", "K960011", "K934738", "K033317", "K243750", "K935064", "K132362", "K082659", "K944292", "K082044", "K033269", "K932434", "K102931", "K944415", "K980815", "K070151", "K160117", "K073671", "K172666", "K940967", "K945202", "K030170", "K070352", "K090470", "K110829", "K210266", "K211309", "K120147", "K955479", "K935756", "K934174", "K954641", "K171886", "K231553", "K002398", "K023843", "K090419", "K991500", "K970720", "K160149", "K000717", "K201744", "K132232", "K061770", "K252400", "K172775", "K003949", "K231240", "K963999", "K962493", "K081853", "K003102", "K181141", "K070671", "K191439", "K944435", "K973313", "K070686", "K974137", "K213271", "K073644" ], "registration_number": [ "3021551844", "1218017", "9612501", "3009956343", "3001169357", "2953359", "3015183635", "3021721805", "9617547", "3014328942", "2245304", "1225798", "2936485", "3017636737", "3017210488", "3021632375", "9610612", "3010202439", "1527736", "1422634", "3010432890", "3018094310", "1220477", "3015185328", "3014461810", "1651252", "2647580", "3014279513", "3011137372", "1319660", "3013188547", "3005075853", "3009380063", "1018470", "9710649", "3010383847", "3012358417", "3005099803", "3014479313", "2020550", "3022505496", "3031276312", "3004450679", "1721676", "1650907", "3035387162", "9681260", "3007695959", "3005941719", "3010041511", "1058584", "3002907620", "1000121056", "1219930", "3017196117" ], "fei_number": [ "3021551844", "1218017", "1000136478", "3009956343", "3002681132", "3001169357", "3000215205", "3015183635", "3021721805", "3014328942", "3003495548", "2245304", "2936485", "3002806565", "3017636737", "3017210488", "3021632375", "3005747797", "1527736", "3010432890", "3018094310", "3002770040", "1220477", "3015185328", "3014461810", "3001595430", "2647580", "3014279513", "1000219637", "3002807111", "3003565435", "3013188547", "3005075853", "3009380063", "3003272809", "1018470", "3010383847", "3002806315", "3012358417", "3005099803", "3014479313", "2020550", "3007475226", "3022505496", "3031276312", "3004450679", "1721676", "3035387162", "3007695959", "3010041511", "1000514656", "3002907620", "1000121056", "1219930", "3017196117" ], "device_name": "Endoscopic Tissue Approximation Device", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }