{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "222047", "product_res_number": "Z-3188-2026", "event_date_initiated": "2026-07-22", "event_date_posted": "2026-09-16", "recall_status": "Open, Classified", "res_event_number": "99630", "product_code": "FGB", "k_numbers": [ "K233645" ], "product_description": "Boston Scientific Corporation\r\nStoneSmart Connect Console\r\nContents: (1) Power Cord, (1) Power Adaptor, (1)DVI Cable, (1) DVI to HDMI Cable, (1) DisplayPort Cable\r\nREF: M0067933000, M006793300H0, M006793300R0, M006793300D0, M006793300Z0, M0067930000, M006793000R0", "code_info": "All Serial Numbers: \nREF: M0067933000 (UDI 00191506002510, UDI (00191506021771);\nREF: M006793300H0 (UDI 00191506002558); \nREF: M006793300R0 (UDI 00191506002534), UDI (00191506021788);\nREF: M006793300D0 (UDI 00191506002527);\nREF: M006793300Z0 (UDI 00191506002541);\nUPN M0067933100 (UDI 00191506022549)", "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": "Clara Johnson\n763-494-1133", "reason_for_recall": "A subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result, the power adaptor may fail electrical safety testing during installation.", "root_cause_description": "Nonconforming Material/Component", "action": "On July 22, 2026, Boston Scientific Corporation issued a medical device correction to affected consignees via FedEx letter, Boston Scientific Corporation requested consignees to take the following actions:\n\n1. Continue to use the affected devices according to the Instructions for Use.\n\n2. Forward this notice to relevant personnel and any facilities to which the\nimpacted device was transferred.\n\n3. Complete and return the enclosed Acknowledgement Form.\n\n4. Begin using the replacement power adaptor upon receipt and dispose of the\naffected power adaptor in accordance with local requirements.", "product_quantity": "982 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of AZ, FL, CA, OR, IL, NC, NE, UT, CO, OH, AR, NM, AL, WI, TN, IN, GA, OH, WI, KY, CT, KS, SC, IL, NE, MO, MS, DE, TX, NY, WV, MA, MT, WA, WY, NV, HI, ID, MO, ME, WV, NE, OK, MN, LA, WV, NV, PA, NH, NJ, MI, MO, AK, VA, MS, WY, ME and the countries of Australia, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Lebanon, Norway, Poland, Portugal, Saudi Arabia, Slovakia, Spain, Sweden, Switzerland, Turkiye, Canada, Hong Kong, Singapore, Taiwan, Argentina, Chile, Japan.", "openfda": { "k_number": [ "K221158", "K223466", "K242108", "K231774", "K250785", "K231135", "K951855", "K241598", "K991178", "K811535", "K926004", "K880802", "K915458", "K142556", "K880801", "K171076", "K243857", "K210579", "K220159", "K261153", "K233630", "K012758", "K884153", "K940464", "K243708", "K233372", "K212458", "K213334", "K253505", "K240203", "K982905", "K970427", "K862551", "K241945", "K000200", "K241434", "K960323", "K141250", "K230475", "K252468", "K232911", "K243155", "K252806", "K011325", "K260516", "K233275", "K172298", "K243550", "K233645", "K201293", "K900813", "K253411", "K852888", "K241956", "K990050", "K240074", "K920750", "K251951", "K911411", "K121112", "K052044", "K963855", "K033651", "K904793", "K211686", "K250917", "K250049", "K901214", "K223097", "K241639", "K992527", "K260013", "K180367", "K012925", "K252929", "K233778", "K172098", "K111480", "K240374", "K201897", "K221515", "K211347", "K844143", "K233700", "K011849", "K200369", "K252703", "K003806", "K183188", "K181977", "K153049", "K222737", "K914106", "K131369", "K262552", "K262488", "K230200", "K172246", "K925128", "K062725", "K031278", "K242699", "K964482", "K012951", "K872282", "K883110", "K243117", "K243532", "K902773", "K926423", "K062707", "K023358", "K043021", "K231878", "K923545", "K181451", "K941013", "K243894" ], "registration_number": [ "1820334", "3015139943", "2936485", "3029981244", "3015970743", "2027009", "9614434", "3035710892", "3035480112", "3003915875", "3014615697", "3005465238", "9610691", "3032578846", "3040391040", "3010707607", "3021031769", "3003206812", "3033010858", "3012797688", "3011986317", "8010418", "3008998256", "3017367014", "3005099803", "3005580113", "3014893827", "3014498758", "3028058843", "8010487", "3019807891", "3010273872", "3036978610", "3042940358", "3016045249", "2124215", "3000160970", "9681260", "3016881508", "2183744", "3017425975", "9610877", "3032429484", "3038296436", "8010298", "1825146", "3008776287", "3016690337", "3020746799", "8010047", "3023809956", "3004040397", "3009134855", "3010421104", "3017210488", "3013247477", "3009171251", "3012843412", "1828132", "3022106566", "3004111573", "3032959393", "1418479", "1319639", "3002808148", "3020369549", "3003923762", "1000484830", "3014342096", "8043903", "3014644276", "9610595", "3030504644", "9610773", "9610617", "3003790304", "3010419931", "3004644065", "3014279513", "3015925378", "3003542872", "9611102", "9615001", "3035484431", "1220477", "3003782610", "3008439484", "3037966040", "3011050570", "1221826", "3014683069", "1037955", "3009453258", "3023460764", "3012322232", "3025318945", "3005173255", "3021246306", "3013992977", "3012375451", "3011642792", "3010220595", "3025349506", "1519132", "1000121056", "3002807314", "2020550", "3024021261", "3004361445", "9611612", "3015540957", "3005941719", "3029929134", "3038613058", "3008386005", "3017961114", "2030624", "9616693", "3010202439", "3006546082", "2531475" ], "fei_number": [ "1000138054", "3002806359", "1820334", "3015139943", "2936485", "3029981244", "3015970743", "2027009", "3008185830", "3035710892", "3035480112", "3003915875", "3014615697", "3005465238", "3032578846", "3040391040", "3010707607", "3021031769", "3003206812", "3033010858", "3012797688", "3011986317", "3008998256", "3017367014", "3005099803", "3005580113", "3014893827", "3014498758", "3028058843", "3019807891", "3010273872", "3036978610", "3042940358", "3016045249", "3002808088", "2124215", "3000160970", "3016881508", "2183744", "3032429484", "3038296436", "1825146", "3008776287", "3016690337", "3020746799", "3023809956", "3004040397", "3009134855", "3002807795", "3010421104", "3002808273", "3006759904", "3017210488", "3013247477", "3012843412", "3002808001", "1828132", "3022106566", "3004111573", "3032959393", "1418479", "3002808148", "3020369549", "3002808268", "3002807111", "3002807847", "3002618605", "3003923762", "3000206435", "1000484830", "3001642379", "3014342096", "3030504644", "3003790304", "3010419931", "3004644065", "3014279513", "3015925378", "3003542872", "3002806565", "3035484431", "3007130719", "1220477", "3003782610", "3008439484", "3007475226", "3003922255", "3037966040", "3011050570", "1221826", "3014683069", "1037955", "3009453258", "3023460764", "3012322232", "3025318945", "3005173255", "3021246306", "3013992977", "3002964398", "3012375451", "3011642792", "3003448211", "3010220595", "3025349506", "1519132", "3006149253", "1000121056", "3002807314", "2020550", "3024021261", "3004361445", "3015540957", "3029929134", "3038613058", "3008386005", "4430", "3017961114", "3002807798", "3006546082", "3014447948" ], "device_name": "Ureteroscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }