Is Boston Scientific Neuromodulation Corporation recalled?

Yes — a recall has been published. Reason: 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.

TemporaryFDAOngoing

Can cause harm that is usually temporary.

Intracept Access Instruments, Description/REF: INTRACEPT ACCESS INSTRUMENTS- DRILL/RLV0035, INTRACEPT ACCESS INSTRUMENTS- DRILL EU/RLV0035-EU, INTRACEPT ACCESS INSTRUMENTS- 2VB/RLV0045, INTRACEPT ACCESS INSTRUMENTS- 2VB EU/RLV0045-EU, INTRACEPT ACCESS INSTRUMENTS- 3VB/RLV0055, INTRACEPT ACCESS INSTRUMENTS- 3VB EU/RLV0055-EU, INTRACEPT ACCESS INSTRUMENTS 2 VB/RLV0065, INTRACEPT ACCESS INSTRMNTS ADDITIONAL VB/RLV0075, INTRACEPT ACCESS INSTRMNTS ADDTL VB EU/RLV0075-EU

Check the device or its packaging for

REF/UDI-DI/Lot/Expiration Date Range: RLV0035/852454006240/36231634, 36266333, 36266334, 36266335, 36442451, 36556998, 36577474, 36577475, 37355534, 37374614, 37642257, 37642258, 37667047, 37667049, 38711750, 38711751/04-Mar-2027 to 21-Jul-2027; RLV0035-EU/852454006448/36267790, 36909569, 38889437/04-Mar-2027 to 26-Jun-2027; RLV0045/852454006301/35218150, 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; RLV0045-EU/852454006431/36190488, 36254922, 36411351, 36909570, 37575379, 38654200/11-Feb-2027 to 04-Nov-2027; RLV0055/852454006226/35235794, 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; RLV0055-EU/852454006318/36190489/30-Jan-2027 to 30-Jan-2027; RLV0065/852454006424/37166269, 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; RLV0075/852454006257/35490122, 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; RLV0075-EU/852454006455/36267789, 36932250, 37575378/23-Jan-2027 to 14-Aug-2027

Why: 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.
Distributed: 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.
Company: Boston Scientific Neuromodulation Corporation
Announced: 15 July 2026This is the date the recall was announced. A company may have started it weeks earlier.
Recall began: 22 April 2026

Source: FDA record Z-2694-2026 · retrieved 8 July 2026

Read the official notice

Every recall is shown word for word from the FDA and USDA, with a link to the source.