FDA recall, , Moderate risk
Boston Scientific Neuromodulation Intracept Access Instruments
Intracept Access Instruments may have a sterile barrier breach, which could lead to severe infection.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Neuromodulation Corporation, of Valencia, California, began a recall of Intracept Access Instruments on April 22, 2026, because the instruments may have a sterile barrier breach of the outer tray seal, which may introduce a risk of sterility breach and could lead to severe infection.
The recall was added to the FDA's Enforcement Report and classified on July 8, 2026, and in the FDA's weekly enforcement report on July 15, 2026. The products were distributed nationwide in the United States and in Great Britain, Germany, and the United Arab Emirates.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI and lot code are listed under that product.
A UDI-DI is the device identifier printed with the barcode on the device label.
Intracept Access Instruments, Description/REF
- UDI-DI
- 852454006240
- 36231634
- 36266333
- 36266334
- 36266335
- 36442451
- 36556998
- 36577474
- 36577475
- 37355534
- 37374614
- 37642257
- 37642258
- 37667047
- 37667049
- 38711750
- 38711751
- 852454006448
- 36267790
- 36909569
- 38889437
- 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
- 852454006431
- 36190488
- 36254922
- 36411351
- 36909570
- 37575379
- 38654200
- 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
- 852454006318
- 36190489
- 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
- 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
- 852454006455
- 36267789
- 36932250
- 37575378
- Lot code
- RLV0035
- 04-Mar-2027
- 21-Jul-2027
Recall details
- Company began the recall
- Sold in
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 CorporationValencia, California
- Hazard
- Sterility problem
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98933
- Recall number
- Z-2694-2026
All recalls from Boston Scientific Neuromodulation Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
