Class 2 Device Recall Intracept Access Instruments

• Date Initiated by Firm: April 22, 2026
• Date Posted: July 08, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2694-2026
• Recall Event ID: 98933
• 510(K)Number: K222281
• Product Classification: Probe, radiofrequency lesion - Product Code GXI
• Product: 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
• Code Information: 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
• FEI Number: 3006630150
• Recalling Firm/ Manufacturer: Boston Scientific Neuromodulation Corporation; 25155 Rye Canyon Loop; Valencia CA 91355-5004
• For Additional Information Contact: Renee Archie; 508-683-4523
• Manufacturer 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.
• FDA Determined Cause: 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: 1) Segregate affected devices until they can be returned to firm. 2) 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. 3) Forward this notice to any healthcare professional from your organization for awareness and to any organization to which affected devices have been transferred. 4) Complete and return the enclosed Reply Verification Tracking Form via email to BSCFieldActionCenter@bsci.com Any adverse events or quality concerns associated with use of these devices should be reported to firm via email at mailto: BSCcomplaints@bsci.com or
• Quantity in Commerce: 37,764
• 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GXI