{ "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": "220233", "product_res_number": "Z-2694-2026", "event_date_initiated": "2026-04-22", "event_date_posted": "2026-07-08", "recall_status": "Open, Classified", "res_event_number": "98933", "product_code": "GXI", "k_numbers": [ "K222281" ], "product_description": "Intracept Access Instruments, Description/REF:\nINTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035,\nINTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU,\nINTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045,\nINTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU,\nINTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055,\nINTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU,\nINTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065,\nINTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075,\nINTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU", "code_info": "REF/UDI-DI/Lot/Expiration Date Range:\nRLV0035/852454006240/36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751/04-Mar-2027 to 21-Jul-2027;\n\nRLV0035-EU/852454006448/36267790, 36909569, 38889437/04-Mar-2027 to 26-Jun-2027;\n\nRLV0045/852454006301/35218150, 35218151, 35218152, 35218153, 35219469, 35219470, 35229010, 35229011, 35229012, 35256597, 35318740, 35318741, 35318742, 35329853, 35329854, 35338734, 35360990, 35360991, 35360992, 35406849, 35406850, 35406851, 35406852, 35406853, 35406854, 35498172, 35508065, 35508066, 35523483, 35523484, 35525666, 35535444, 35535445, 35535446, 35535664, 35535665, 35536282, 35538112, 35538113, 35538114, 35538115, 35717797, 35717798, 35717861, 35729587, 35729588, 35729589, 35738091, 35738092, 35738093, 35755411, 35755412, 35755413, 35788378, 35788379, 35788400, 35789578, 35789579, 35789840, 35822293, 35822294, 35822295, 35831721, 35831722, 35831723, 35884013, 35884014, 35884015, 35884018, 35884019, 35884200, 35929731, 35929732, 35929733, 35939403, 35939404, 35939405, 36007510, 36051631, 36051632, 36051633, 36061072, 36061073, 36063527, 36115270, 36115271, 36162140, 36201849, 36211661, 36211662, 36247081, 36247082, 36247083, 36299784, 36299785, 36306155, 36306908, 36312074, 36312075, 36312076, 36327640, 36327641, 36334682, 36334683, 36334684, 36337568, 36337569, 36356333, 36368650, 36368651, 36390837, 36390839, 36390960, 36390962, 36390963, 36411346, 36440610, 36440611, 36451984, 36455377, 36455378, 36528101, 36538547, 36538548, 36554903, 36576169, 36576170, 36576171, 36578105, 36578106, 36578107, 36578108, 36709018, 36714451, 36719971, 36731035, 36731036, 36731037, 36733644, 36733645, 36743247, 36743248, 36765841, 36765842, 36765843, 36778439, 36779700, 36779701, 36789363, 36789364, 36793775, 36793776, 36802652, 36802653, 36802654, 36814178, 36819483, 36819484, 36825817, 36835476, 36839951, 36839952, 36892404, 36892405, 36907158, 36920578, 36931525, 36938443, 36938444, 36938445, 36948565, 36965128, 36977051, 36984738, 37006934, 37006935, 37021399, 37038790, 37060446, 37072745, 37072746, 37115658, 37126596, 37126597, 37143684, 37143685, 37182176, 37182177, 37191624, 37203924, 37210305, 37222391, 37222392, 37248543, 37248544, 37257912, 37278064, 37278065, 37291738, 37422836, 37422837, 37422838, 37434285, 37434286, 37443230,37467700, 37467701, 37467702, 37499290, 37499291, 37513740, 37513741, 37527332, 37558530, 37558531, 37586529, 37604798, 37604928, 37752893, 37752894, 37808050, 37808051, 37818544, 37818545, 37818546, 37864351, 37864352, 37876714, 37876715, 37876716, 37876717, 37909770, 37909771, 37923968, 37941727, 37941728, 38243913, 38243914, 38243915, 38253672, 38253673, 38253674, 38253675, 38257979, 38258120, 38258121, 38393517, 38393518, 38461277, 38461278, 38462080, 38462081, 38462082, 38462587, 38472779, 38473000, 38473001, 38473954, 38484605, 38484606, 38496711, 38517754, 38531680, 38600809, 38600810, 38600811, 38600812, 38632672, 38632673, 38632674, 38711753, 38712187, 38917000, 38917002, 39009366/03-Oct-2026 to 03-Mar-2028;\n\nRLV0045-EU/852454006431/36190488, 36254922, 36411351, 36909570, 37575379, 38654200/11-Feb-2027 to 04-Nov-2027;\n\nRLV0055/852454006226/35235794, 35235795, 35235796, 35235797, 35235798, 35235799, 35235940, 35244678, 35244679, 35245420, 35265922, 35309126, 35309128, 35309130, 35316016, 35328273, 35328274, 35367311, 35367312, 35367313, 35453674, 35461292, 35461293, 35461294, 35461295, 35461296, 35469325, 35469326, 35469327, 35498173, 35498174, 35508414, 35508415, 35516633, 35518863, 35518864, 35520116, 35522815, 35522816, 35522817, 35522818, 35530433, 35530434, 35582150, 35582151, 35582152, 35585353, 35585354, 35590649, 35590650, 35738094, 35738095, 35738096, 35738097, 35738098, 35738099, 35780448, 35780449, 35780450, 35789910, 35789911, 35789912, 35796422, 35796423, 35796424, 35831784, 35831785, 35831786, 35841864, 35841865, 35841866, 35849369, 35849370, 35849371.35871196, 35871197, 35871198, 35890764, 35890765, 35890766, 35989202, 35989203, 35989204, 36042033, 36042034, 36042035, 36051634, 36051635, 36051636, 36103927, 36103928, 36103930, 36168356, 36201850, 36254923, 36254924, 36258582, 36299786, 36299787, 36306157, 36306158, 36306159, 36315014, 36315015, 36327258, 36327259, 36334687, 36334688, 36334689, 36346737, 36346738, 36346739, 36346800, 36356510, 36356511, 36368652, 36368653, 36377745, 36421406, 36421407, 36421408, 36442449, 36442450, 36455379, 36466553, 36466554, 36474482, 36509579, 36509640, 36511507, 36518452, 36518454, 36519641, 36519642, 36538550, 36588268, 36588269, 36588270, 36588271, 36588273, 36627806, 36779702, 36779703, 36779704, 36789365, 36796277, 36796278, 36801923, 36879218, 36879219, 36879300, 36885626, 36885627, 36948834, 37018069, 37018070, 37021397, 37021398, 37030573, 37038794, 37060447, 37072747, 37072748, 37072749, 37085884, 37085885, 37097347, 37097348, 37097349, 37097352, 37105997, 37105998, 37114545, 37143682, 37143683, 37234124, 37234125, 37248545, 37266940, 37266941, 37278066, 37291818, 37291819, 37422839, 37423650, 37423651, 37434287, 37434288, 37476160, 37476161, 37486544, 37513375, 37513376, 37517300, 37527333, 37527334, 37527335, 37528240, 37528241, 37548528, 37548529, 37548530, 37548532, 37576081, 37586522, 37586530, 37597563, 37597564, 37606989, 37606990, 37606992, 37723478, 37752895, 37752896, 37752897, 37771990, 37771991, 37771993, 37772123, 37772124, 37772125, 37864353, 37864354, 37864355, 37885352, 37885353, 37930763, 37930764, 37930765, 37954165, 37954166, 37954167, 37954168, 38048470, 38196327, 38196328, 38243169, 38243170, 38252987, 38252988, 38252989, 38287216, 38287217, 38287218, 38404416, 38462594, 38474849, 38474880, 38474881, 38481950, 38481954, 38483325, 38496708, 38496709, 38529820, 38531658, 38531659, 38537775, 38540454, 38540782, 38540792, 38614681, 38711754, 38712189/10-Oct-2026 to 29-Oct-2027;\n\nRLV0055-EU/852454006318/36190489/30-Jan-2027 to 30-Jan-2027;\n\nRLV0065/852454006424/37166269, 37166270, 37205965, 37422790, 37422791, 37434847, 37434848, 37822997, 37822998, 37822999, 37837635, 37837636, 37837637, 37859920, 37903427, 37903428, 37909761, 37930774, 37930775, 37980230, 37980231, 37980232, 37980233, 38079204, 38079205, 38079206, 38079207, 38107765, 38107766, 38107767, 38107768, 38135922, 38135923, 38135924, 38154984, 38154985, 38159015, 38166823, 38166824, 38166825, 38166826, 38166827, 38166828, 38169819, 38170180, 38170693, 38170694, 38205657, 38205658, 38205659, 38222326, 38222327, 38222328, 38222329, 38222330, 38243916, 38339417, 38339418, 38339419, 38339880, 38339881, 38347588, 38355042, 38358582, 38358583, 38358584, 38360834, 38360835, 38366171, 38384137, 38384138, 38384139, 38392693, 38404412, 38404413, 38412000, 38412001, 38412003, 38412005, 38412006, 38412007, 38415242, 38415246, 38529822, 38531280, 38531281, 38559204, 38559205, 38559206, 38559207, 38568272, 38580272, 38580273, 38580274, 38580275, 38589983, 38589984, 38589985, 38590380, 38590381, 38590382, 38590383, 38590384, 38590385, 38590386, 38590387, 38590388, 38597090, 38623873, 38623874, 38623875, 38623876, 38632676, 38632678, 38643661, 38645060, 38645061, 38645062, 38645063, 38692073, 38692074, 38692075, 38692076, 38703597, 38708720, 38708721, 38708722, 38708723, 38712509, 38712511, 38712512, 38739451, 38739453, 38739454, 38739455, 38750004, 38750005, 38750007, 38774400, 38774401, 38802555, 38802556, 38802557, 38802558, 38809866, 38812686, 38812687, 38812688, 38821188, 38821189, 38821191, 38823209, 38823210, 38858563, 38858564, 38858565, 38858566, 38858570, 38869945, 38870375, 38870378, 38870783, 38870784, 38878535, 38878536, 38878538, 38878539, 38879225, 38879226, 38949331, 38949332, 38949333, 38949334, 39032543/30-Jul-2027 to 15-Mar-2028;\n\nRLV0075/852454006257/35490122, 35490123, 35490124, 35490125, 35490126, 35604788, 35615708, 35615709, 35705365, 35705366, 35901453, 35901454, 35901455, 35936488, 35936489, 35998826, 35998827, 35998828, 36159579, 36254921.36349203, 36349204, 36404502, 36404503, 36421409, 36835470, 36870653, 36870654, 36874432, 36874433, 36929050, 36929051, 36929052, 36929053, 36929054, 36983480, 36983481, 37060448, 37107838, 37107839, 37191554, 37191555, 37191556, 37204731, 37210306, 37335984, 37355535, 37364022, 37535449, 37535450, 37752898, 37943227, 37976478, 37976479, 37977720, 37977721, 38048471, 38179848, 38249218, 38249700, 38249991, 38253644, 38253645, 38253670, 38253671, 38347590, 38384136, 38426598, 38451722, 38451723, 38508092, 38529821, 38531016, 38539792, 38540765, 38540766, 38655662, 38730788, 38763797, 38763799/29-Oct-2026 to 21-Nov-2027;\n\nRLV0075-EU/852454006455/36267789, 36932250, 37575378/23-Jan-2027 to 14-Aug-2027", "firm_fei_number": "3006630150", "recalling_firm": "Boston Scientific Neuromodulation Corporation", "address_1": "25155 Rye Canyon Loop", "city": "Valencia", "state": "CA", "postal_code": "91355-5004", "additional_info_contact": "Renee Archie\n508-683-4523", "reason_for_recall": "Intraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach, and if breached could lead to severe infection.", "root_cause_description": "Packaging process control", "action": "On 4/22/2026, removal notices were mailed to materials managers and health care professionals who were asked to do the following:\n\n1) Segregate affected devices until they can be returned to firm.\n2) Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device.\n3) Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred.\n4) Complete and return the enclosed Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com\n\nAny adverse events or quality concerns associated with use of these devices should be reported to firm via email at mailto: BSCcomplaints@bsci.com or", "product_quantity": "37,764", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of NJ, WI, MI, MN, AR, UT, OH, FL, CA, TX, PA, AZ, IN, LA, NE, OK, NY, MD, WY, CO, NC, IL, GA, WA, KS, AL, MO, VA, TN, KY, MS, MA, SC, OR, WV, MT, ID, SD, CT, NV, ND, NH, DE, NM, AK, IA, DC, HI, ME, VT, RI and the countries of Great Britain, Germany, United Arab Emirates.", "openfda": { "k_number": [ "K191293", "K152642", "K884347", "K050084", "K053415", "K101372", "K001588", "K991399", "K032196", "K141586", "K802243", "K053082", "K163461", "K170708", "K000073", "K163236", "K042375", "K190504", "K080771", "K994344", "K071300", "K180369", "K242841", "K880293", "K032406", "K112231", "K250213", "K222281", "K980430", "K203066", "K062946", "K251802", "K090608", "K092337", "K021942", "K153272", "K213836", "K041021", "K880925", "K060397", "K251243", "K060799", "K011387", "K170827", "K880951", "K043442", "K190256", "K062937", "K972846", "K082012", "K183177", "K002389", "K071745", "K110593", "K241367", "K150371", "K253907", "K090955", "K121773", "K882802", "K870028", "K034012", "K190259", "K123178", "K102566", "K063467" ], "registration_number": [ "3010966701", "3017423051", "3004122598", "1319639", "1030489", "2124215", "3007695959", "2133786", "3005941719", "3004762958", "9616662", "1222773", "3015967359", "9611665", "3006950086", "3003365815", "3007997036", "3033589330", "3008102042", "3010273872", "1644312", "3004617090", "3005160949", "2183744", "3009732568", "3010034260", "1720929", "3003477135", "9680425", "9616693", "3015309643", "3013302242", "3007221462", "3015924373", "3007029079", "3029990829", "1000632857", "3013111980", "1721504", "9680001", "3008534770", "1450662", "1643817", "3005334138", "3015443199", "1316297", "3008998256", "2182269", "3030733800", "1526711", "3006630150", "1313525", "8010177", "1627487", "1928237", "9611612", "3004785273", "2030624", "3011270181", "3020968442", "3008837339", "3016438686", "3012536737", "1225687", "2032521", "3021008900", "3018094310", "1221485", "3009766315", "1721983", "8043398", "1643059", "3008559295", "3009823392", "2029275", "3016678045", "1721676", "3015173212", "1000121056", "1224960", "3043527620", "3009241989", "3003120897", "1920664", "2182979" ], "fei_number": [ "3010966701", "3002618605", "3017423051", "3004122598", "1000064530", "2124215", "3002807095", "3007695959", "3003574398", "3002807111", "3002807847", "3004762958", "3015967359", "1000306431", "3006950086", "3003365815", "3007997036", "3033589330", "3010273872", "1000117748", "3004617090", "3005160949", "3000204692", "3000335778", "3002821504", "2183744", "3009732568", "3010034260", "1720929", "3003477135", "1000138054", "3015309643", "3013302242", "1000477302", "3007221462", "3002808445", "3015924373", "3007029079", "3029990829", "1000632857", "3013111980", "1721504", "3008534770", "3000206435", "3003630373", "1450662", "1643817", "3005334138", "3015443199", "1316297", "3008998256", "2182269", "3030733800", "1526711", "3002924544", "3006630150", "1627487", "1928237", "3004785273", "1000120768", "3011270181", "3020968442", "3008837339", "3016438686", "3012536737", "1317628", "3021008900", "3018094310", "1221485", "3009766315", "1643059", "3008559295", "3009823392", "3016678045", "1721676", "3015173212", "3007596547", "1000121056", "3000204727", "3043527620", "3009241989", "3003120897", "1920664", "3001451463", "2182979" ], "device_name": "Probe, Radiofrequency Lesion", "medical_specialty_description": "Neurology", "regulation_number": "882.4725", "device_class": "2" } } ] }