FDAClass II · Medical device · Recalled July 15, 2026

Intracept Access Instruments recall — Boston Scientific Neuromodulation Corporation

View the official FDA enforcement record (openFDA) ↗

Official recall ID

Z-2694-2026

Brand

Boston Scientific Neuromodulation

Classification

Class II

Units affected

37,764

Recall status

Ongoing

Initiated

Voluntary: Firm initiated

Description

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

Affected products

• Intracept Access Instruments

Companies & origin

Recalling firm location

Valencia, CA, United States

Firm address

25155 Rye Canyon Loop, N/A, 91355-5004

Identifying details (verbatim from the notice)

Product codes / lots

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

Distribution

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.

Firm notified the public via

Letter

FDA event ID

98933

Recall initiated

April 22, 2026

FDA classified

July 8, 2026

FDA report date

July 15, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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