{ "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": 3 } }, "results": [ { "cfres_id": "185563", "product_res_number": "Z-1168-2021", "event_date_initiated": "2021-01-19", "event_date_created": "2021-03-04", "recall_status": "Open, Classified", "res_event_number": "87221", "product_code": "FDI", "k_numbers": [ "K202478" ], "product_description": "Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares. \n\nOuter box UPN, Inner Pouch UPN: \nM00561311 (Box 10), M00561310\nM00562301 (Box 10), M00562300; \nM00562321 (Box 10), M00562320; \nM00562341 (Box 10), M00562340; \nM00562451 (Box 10), M00562450; \nM00562401 (Box 10), M00562400; \nM00562402 (Box 40), M00562400; \nM00562422 (Box 40), M00562420; \nM00562471 (Box 10), M00562470.", "code_info": "Outer box GTIN: 08714729019251 Inner pouch GTIN: 08714729747680 Lot/Batch#: 24725319, 24782695,   Outer box GTIN: 08714729019312 Inner pouch GTIN: 08714729747833 Lot/Batch#: 24842597, 24812577,   Outer box GTIN: 08714729019336 Inner pouch GTIN: 08714729747857 Lot/Batch#: 24889757, 24719202, 24709536, 24773287,   Outer box GTIN: 08714729019350 Inner pouch GTIN: 08714729747871 Lot/Batch#: 24782693, 24732964, 24889755, 24780939,   Outer box GTIN: 08714729071068 Inner pouch GTIN: 08714729747970 Lot/Batch#: 24882357, 24782689, 24782687, 24729758,   Outer box GTIN: 08714729019411 Inner pouch GTIN:08714729747932 Lot/Batch#: 24961643  Outer box GTIN:08714729501640 Inner pouch GTIN: 08714729747932 Lot/Batch#: 24961645, 24989260, 24844193,   Outer box GTIN:08714729501657 Inner pouch GTIN:08714729747956 Lot/Batch#: 25010054,   Outer box GTIN:08714729019459 Inner pouch GTIN:08714729747994 Lot/Batch#: 25016793.", "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": "Nicole Pshon\n763-494-1133", "reason_for_recall": "Packaging Incomplete Seal. Users noted an incomplete pouch seal prior to using the device in a patient.", "root_cause_description": "Process change control", "action": "On 01/21/2021, Boston Scientific issued Urgent Medical Device Product Removal notices to customers via e-mail. The removal notice is due to an incomplete seal of the inner pouch which could result in a sterile barrier breach rendering the specified lots of polypectomy snare devices non-sterile.", "product_quantity": "335,788 units total (Domestic: 222,882, Foreign: 112,906)", "distribution_pattern": "US nationwide distribution.", "openfda": { "k_number": [ "K943935", "K930022", "K221713", "K083049", "K150316", "K202478", "K951600", "K220846", "K893553", "K103611", "K894869", "K182909", "K172758", "K845016", "K970356", "K924105", "K142258", "K190512", "K200745", "K950496", "K942110", "K011667", "K133513", "K022268", "K002927", "K073288", "K151197", "K213222", "K923671", "K131700", "K133987", "K220089", "K172729", "K955650", "K020891", "K960230", "K160637", "K191048", "K941750", "K140763", "K212860", "K971275", "K251692", "K992477", "K911482", "K091355", "K122462", "K123223", "K901428", "K050294", "K152580", "K140726", "K902265", "K940335", "K183289", "K901322", "K140923", "K172734", "K220790", "K912254", "K173673", "K923031", "K040961" ], "registration_number": [ "3011193403", "1223925", "3004083736", "1222168", "3005987240", "3011270181", "1047843", "1643817", "3008040402", "3007305485", "1320894", "1064858", "3023102955", "3006546082", "1820334", "2246552", "3009888344", "3010288205", "3013460719", "3003782610", "3012042439", "1225687", "3006696607", "3012494290", "3010273872", "9680809", "3004837686", "3021023752", "9610617", "3010202439", "3017390965", "3013526170", "3010707607", "2020550", "9681260", "3008720584", "8010047", "3014620201", "3014769442", "3002807314", "3004784537", "3013440400", "2183446", "3009217531", "1000393132", "1825146", "3004129994", "3014342096", "9611283", "9614641", "3007695959", "1721686", "1037905", "3003780911", "3005099803", "1000121056", "3035434483", "2528981", "1528319", "3007738736", "3011050570", "3011146996", "9610877" ], "fei_number": [ "3011193403", "1000122656", "3004083736", "1222168", "3005987240", "3002806816", "3011270181", "1047843", "1643817", "3008040402", "3007305485", "3006546082", "3023102955", "1820334", "2246552", "3009888344", "3010288205", "3013460719", "3003782610", "3012042439", "3008397795", "3006696607", "3012494290", "1000305720", "3010273872", "3004837686", "3021023752", "3017390965", "3013526170", "3010707607", "2020550", "3002995060", "3002807795", "3008720584", "3014620201", "3014769442", "3002807314", "3004784537", "3013440400", "2183446", "3009217531", "1000393132", "1825146", "3004129994", "3003995201", "3014342096", "3008185830", "3007475226", "3007695959", "1721686", "1037905", "3001451571", "3003780911", "3005099803", "3002806565", "1000121056", "3035434483", "2528981", "3007738736", "3002808268", "3011050570", "3011146996", "3001451463" ], "device_name": "Snare, Flexible", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4300", "device_class": "2" } } ] }