{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "113532", "product_res_number": "Z-0080-2013", "event_date_initiated": "2012-09-17", "event_date_posted": "2012-10-18", "recall_status": "Terminated", "event_date_terminated": "2013-07-17", "res_event_number": "63336", "product_code": "JOS", "k_numbers": [ "K012315" ], "product_description": "Leveen Coaccess Needle Electrode (3.5/15) and (4.0/15).\n\n Disposable, monopolar, electrosurgical devices, intended for use in conjunction with BSC radiofrequency generator for the thermal coagulation necrosis of soft tissues, including partial or complete ablation of nonresectable liver lesions.", "code_info": "Material Catalog Number: MOO1262230 with lot numbers: 12293473, 12580337, 12639146, 12639181, 12642715,12647752,12651931,12653869, 12656587, 12663028, 12663626, 12667129, 12667787, 12741165, 12760565, 12799352, 12825090, 12849385, 12860811, 12895401, 12967872, 13002918, 13058416, 13096459, 13120668, 13166239, 13235239, 13309477, 13383272, 13399503, 13418415, 13463515, 13498936, 13545732, 13559348, 13665665, 13775008, 13805295, 13822358, 13872667, 13902427, 14076298, 14119776, 14131133, 14169885, 14206936, 14279112, and 14288333.  Material Catalog Number: MOO1262240 with lot numbers: 12341198, 12341781, 12348901, 12351784, 12533460,12533461,12533466,12533467, 12533468, 12600849, 12642716, 12651932, 12663627, 12663628, 12663629, 12667788, 12674036, 12674312, 12741166, 12771577, 12805833, 12805835, 12860812, 12876589, 12937149, 12953904, 12982469, 13020096, 13048075, 13075112, 13117330, 13169619, 13230606,13247208, 13254418, 13278009, 13299117, 13309317, 13352191, 13384075, 13415014,13476371, 13480767, 13545557, 13592399, 13605018, 13610851, 13677260, 13727387,13775007, 13798432, 13813580, 13822357,13837691, 13873878, 13875213, 13883193, 13883196, 13936544, 13940480, 13978762,14076299, 14096255, 14157926, 14169886,14169887, 14217955, and 14249334.", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "reason_for_recall": "Leveen Standard and Leveen Coaccess Needle Electrode System, Directions for Use(DFU) in Portuguese, are incorrect. all other languages in the DFU are correct. Consignees in Brazil, Portugal,and Hong-Kong are being notified.", "root_cause_description": "Labeling Change Control", "action": "Boston Scientific sent notifications, dated September 17, 2012, to each account in Brazil, Portugal and Hong Kong affected by the recall. The affected accounts were provided the corrected pages of the Portuguese DFU as part of the communication to ensure that those users that rely on the Portuguese DFU have the correct information.", "product_quantity": "19,716 units distributed total", "distribution_pattern": "Distributed in Brazil, Portugal and Hong Kong.", "openfda": { "k_number": [ "K952290", "K011515", "K890973", "K873655", "K903302", "K955636", "K780405", "K923037", "K882421", "K891400", "K962313", "K012684", "K881144", "K161600", "K890972", "K993885", "K973554", "K991830", "K944992", "K874719", "K873653", "K050923", "K881763", "K003403", "K950455", "K000333", "K905060", "K895331", "K962544", "K974735", "K810628", "K952323", "K873654", "K772160", "K971187", "K792365" ], "registration_number": [ "1721251", "3013188547", "1222993", "9610773", "3026612481", "3012494290", "1219619", "3004491689", "1319639", "1320894", "3018094310", "9610849", "3007960282", "3010202439", "1319660", "2183744", "3009762450", "3004784537", "3006546082", "3014891416", "9681191", "1061927", "3007544634", "3008361498", "1721194", "2434839", "2219920", "3013557681", "3012322232", "3015136673", "2020550", "8010510", "3002808022", "1018470", "3013557562", "3016678045", "3011050570", "1220477", "1058584", "9680721", "3013247477", "1717344", "9610617", "3007421149", "3009241989", "3043226252", "3007305485", "9610614", "3010707607", "3014342096", "1017294", "8040510" ], "fei_number": [ "1721251", "3013188547", "3000203000", "1000219637", "3026612481", "3012494290", "3001451571", "1219619", "3004491689", "3002807798", "3018094310", "3007960282", "3007475226", "2183744", "3009762450", "3004784537", "3006546082", "3014891416", "3007544634", "3008361498", "3002807391", "2434839", "3000226659", "2219920", "3001319476", "3013557681", "3012322232", "3008207730", "3015136673", "1000138054", "2020550", "3002808022", "1018470", "3013557562", "3016678045", "3011050570", "1000136478", "3013247477", "1717344", "1220477", "1000244733", "3007421149", "3009241989", "3043226252", "3007305485", "1000120578", "3010707607", "3014342096", "3002808268", "1017294", "3002806920", "1721194" ], "device_name": "Electrode, Electrosurgical", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4400", "device_class": "2" } } ] }