Stryker Sustainability Solutions Ethicon XCEL Bladeless Trocars
Reusable access port system may crack or seperate during use.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Stryker Sustainability Solutions of Tempe, Arizona, recalled certain XCEL BLADELESS TROCAR products because the reusable access port system may crack or seperate during use. The recall began August 19, 2026, and the FDA classified it on September 16, 2026.
The products were distributed in Alaska, Alabama, Arkansas, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia, Wyoming, District of Columbia and Puerto Rico.
Summary by Recall Canary from the FDA notice.
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?
6 products
Affected if its UDI-DI and lot code are listed under that product.
REF:B5LT Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar W/Stability Sleeve 5X100MM
- UDI-DI
- 00885825014193
- 16028826
- 16028944
- 16032429
- 16032455
- 16037857
- 16042594
- 16043150
- 16046641
- 16048041
- 16048162
- 16052733
- 16062124
- 16066285
- 16070101
- 16070223
- 16070912
- 16074744
- 16084153
- 16087588
- Lot
- 16096162
- 16098296
- 16099148
- 16111195
- 16111423
- 16112459
- 16115071
- 16120538
- 16126420
- 16126902
- 16131433
- 16135397
- 16135402
- 16139681
- 16140445
- 16142642
- 16142674
- 16146017
- 16146188
- 16146587
- 16147022
- 16155907
- 16156189
- 16160070
- 16160805
- 16160867
- 16161367
- 16168109
- 16168270
- 16172196
- 16172940
- 16177138
- 16177252
- 16180562
- 16188453
- 16189060
- 16189428
- 16192354
- 16192768
- 16197315
- 16201740
- 16202087
- 16202127
- 16207388
- 16210404
- 16213753
- 16214274
- 16214290
- 16222349
- 16224767
- 16225404
- 16229770
- 16233367
- 16237281
- 16238596
- 16246288
- 16247086
- 16247491
- 16252145
- 16259463
- 16266998
- 16270336
- 16273726
- 16273956
- 16281200
- 16281683
- 16285515
- 16293349
- 16298285
- 16298478
- 16303182
- 16303680
- 16306399
- 16310061
- 16310747
- 16313556
- 16317868
- 16331016
- 16331380
- 16335107
- 16338939
- 16339687
- 16339734
- 16346961
- 16347809
- 16347813
- 16354890
- 16359193
- 16376457
- 16379762
- 16379864
- 16379961
- 16383758
- 16387666
- 16397456
- 16397619
- 16397931
- 16403371
- 16407611
- 16408119
- 16412167
- 16412599
- 16414020
- 16414054
- 16414065
- 16422560
- 16422600
- 16422933
- 16427552
- 16431525
- 16432498
- 16432507
- 16436431
- 16439954
- 16444010
- 16444567
- 16447384
- 16448499
- 16463568
- 16463942
- 16467181
- 16467650
- 16470838
- 16471034
- 16478044
- 16482171
- 16483326
- 16486966
- 16494727
- 16494935
- 16500081
- 16503467
- 16508223
- 16512647
- 16514742
- 16514973
- 16520919
- 16521034
- 16523273
- 16523549
- 16523565
- 16528044
- 16532204
- 16532215
- 16535609
- 16536045
- 16540085
- 16540333
- 16540517
- 16540689
- 16547526
- 16548167
- 16548318
- 16551731
- 16558496
- 16564366
- 16569596
- 16569622
- 16574212
- 16574659
- 16579579
- 16584194
- 16587228
- 16587581
- 16587599
- 16587736
- 16591025
- 16595892
- 16596095
- 16596114
- 16600039
- 16603754
- 16604695
- 16609142
- 16609161
- 16614416
- 16615103
- 16623186
- 16623193
- 16626466
- 16626497
- 16626654
- 16626665
- 16632209
- 16642253
- 16642426
- 16645809
- 16656924
- 16656969
- 16660783
- 16661882
- 16665794
- 16665827
- 16670396
- 16671062
- 16674801
- 16675678
- 16679865
- 16679877
- 16682151
- 16682770
- 16687462
- 16692140
- 16692172
- 16692268
- 16696265
- 16700452
- 16700900
- 16705193
- 16709261
- 16709385
- 16709597
- 16709610
- 16713775
- 16713781
- 16716514
- 16717266
- 16721050
- 16721916
- 16725305
- 16725875
- 16725966
- 16728591
- 16732890
- 16737969
- 16741456
- 16741879
- 16742023
- 16745357
- 16745771
- 16746452
- 16749189
- 16750018
- 16754567
- 16755302
- 16758520
- 16763958
- 16764025
- 16767256
- 16767679
- 16768101
- 16768268
- 16774043
- 16778869
- 16781973
- 16785617
- 16789405
- 16792840
- 16793382
- 16796858
- 16797142
- 16797347
- 16807208
- 16811095
- 16811228
- 16811568
- 16814350
- 16814418
- 16817477
- 16817757
- 16817788
- 16817987
- 16826107
- 16826370
- 16826963
- 16833717
- 16834312
- 16834349
- 16837699
- 16838194
- 16838333
- 16841260
- 16841916
- 16842018
- 16845474
- 16849412
- 16850166
- 16854162
- 16854213
- 16857842
- 16860629
- 16860751
- 16860767
- 16860831
- 16869637
- 16869721
- 16872825
- 16873251
- 16877561
- 16877883
- 16878069
- 16886421
- 16886935
- 16890605
- 16892824
- 16893355
- 16894173
- 16899699
- 16902792
- 16908076
- 16911020
- 16911293
- 16919131
- 16922631
- 16922893
- 16923209
- 16926760
- 16927072
- 16936127
- 16936353
- 16936617
- 16936849
- 16943569
- 16949133
- 16951816
- 16953009
- 16954618
- 16959414
- 16960486
- 16963979
- 16964534
- 16964919
- 16969877
- 16973313
- 16978181
- 16980910
- 16984757
- 16985053
- 16987949
- 16997152
- 16997388
- 17001621
- 17004314
- 17005585
- 17010314
- 17010435
- 17013747
- 17013969
- 17017025
- 17020363
- 17020787
- 17024283
- 17024616
- 17035669
- 17036024
- 17041234
- 17041247
- 17050307
- 17053749
- 17055829
- 17055864
- 17060150
- 17063361
- 17067202
- 17070414
- 17076883
- 17081132
- 17084251
- 17085588
- 17089008
- 17095605
- 17099768
- 17099821
- 17103507
- 17103873
- 17109409
- 17116792
- 17116802
- 17120683
- 17120840
- 17131833
- 17131867
- 17135991
- 17136260
- 17136475
- 17139574
- 17147250
- 17151322
- 17155294
- 17158669
- 17159832
- 17165781
- 17165911
- 17169963
- 17171111
- 17173926
- 17173935
- 17190539
- 17199367
- 17199403
- 17199419
- 17199658
- 17204598
- 17205855
- 17209824
- 17219974
- 17227455
- 17228106
- 17235978
- 17235984
- 17247109
- 17249835
- 17250583
- 17250900
- 17254806
- 17254810
- 17258503
- 17258975
- 17259005
- 17266994
- 17267162
- 17275181
- 17281708
- 17282387
- 17282445
- 17285944
- 17286328
- 17286337
- 17290122
- 17293900
- 17299077
- 17303639
- 17304084
- 17321419
- 17321670
- 17325362
- 17325614
- 17333371
- 17337653
- 17341257
- 17358207
- 17363462
- 17364053
- 17378201
- 17378553
- 17378650
- 17403073
- 17407979
- 17412823
- 17413288
- 17417109
- 17417579
- 17417676
- 17425678
- 17425887
- 17436001
- 17436040
- 17441287
- 17442039
- 17448781
- 17454162
- 17468565
- 17471347
- 17474066
- 17481348
- 17482218
- 17491511
- 17492064
- 17505393
- 17512416
- 17517569
- 17520689
- 17525578
- 17532462
- 17535912
- 17536383
- 17545136
- 17550422
- 17557081
- 17557132
- 17565241
- 17565764
- 17571924
- 17575872
- 17576264
- 17580429
- 17590902
- 17591112
- 17596913
- 17600177
- 17600219
- 17600226
- 17600274
- 17600328
- 17602104
- 17602975
- 17603011
- 17606494
- 17614337
- 17618361
- 17618716
- 17623697
- 17623873
- 17635903
- 17641398
- 17641403
- 17645985
- 17655904
- 17664504
- 17664897
- 17669134
- 17669357
- 17678849
- 17688093
- 17688998
- 17692201
- 17703119
- 17708606
- 17712528
- 17713130
- 17715999
- 17722453
REF:B5ST Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar W/Stability Sleeve 5X75MM
- UDI-DI
- 00885825014254
- 16028740
- 16083100
- 16098933
- 16106547
- 16130667
- 16160384
- 16160418
- 16160460
- 16181332
- 16201793
- 16207031
- 16234052
- 16264116
- 16418941
- 16421915
- 16422882
- 16476685
- 16493231
- 16948345
- Lot
- 16954673
- 16977948
- 16993151
- 17151380
- 17160201
- 17210355
- 17239624
- 17271015
- 17271027
- 17324927
- 17341521
- 17342144
- 17378894
- 17412852
- 17426084
- 17457260
- 17491569
- 17499741
- 17512459
- 17521310
- 17526338
REF:B12LT Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar W/Stability Sleeve 12X100MM
- UDI-DI
- 00885825020897
- 16029001
- 16032878
- 16038822
- 16041414
- 16044000
- 16048542
- 16052751
- 16054119
- 16062169
- 16062738
- 16066292
- 16074632
- 16087947
- 16087952
- 16090650
- 16098040
- 16107246
- 16111434
- 16115899
- Lot
- 16115909
- 16120868
- 16130680
- 16130701
- 16135456
- 16136279
- 16138395
- 16140432
- 16140568
- 16142544
- 16142619
- 16159304
- 16160563
- 16172080
- 16176548
- 16186738
- 16186874
- 16187194
- 16187248
- 16187457
- 16197336
- 16201786
- 16205783
- 16205810
- 16205823
- 16206753
- 16220653
- 16220918
- 16221448
- 16221453
REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar W/Optiview Technology & Sleeve 5MM X 100MM
- UDI-DI
- 00885825017248
- 16029709
- 16029713
- 16029905
- 16038879
- 16038908
- 16048968
- 16048981
- 16051646
- 16052906
- 16053263
- 16070603
- 16070983
- 16074134
- 16074530
- 16074759
- 16092016
- 16092379
- 16092572
- 16104843
- Lot
- 16106180
- 16119023
- 16119800
- 16121093
- 16126431
- 16126844
- 16140581
- 16140608
- 16140727
- 16140736
- 16142688
- 16160592
- 16160707
- 16160912
- 16161351
- 16167914
- 16180911
- 16188469
- 16189136
- 16197549
- 16210951
- 16244569
- 16247119
- 16247126
- 16250185
- 16255569
- 16267787
- 16273355
- 16284965
- 16303304
- 16306443
- 16359846
- 16360045
- 16360239
- 16360667
- 16364426
- 16383244
- 16383259
- 16384055
- 16396887
- 16397027
- 16427445
- 16435623
- 16435843
- 16436420
- 16436477
- 16444099
- 16444580
- 16444611
- 16448679
- 16448717
- 16459282
- 16459305
- 16459333
- 16459564
- 16470988
- 16488281
- 16491642
- 16492270
- 16492579
- 16492580
- 16500270
- 16500301
- 16500355
- 16500477
- 16508036
- 16528627
- 16528847
- 16531603
- 16531776
- 16531851
- 16552151
- 16552167
- 16552179
- 16552302
- 16555583
- 16614437
- 16614471
- 16618155
- 16626048
- 16637792
- 16646115
- 16651856
- 16652489
- 16657339
- 16662201
- 16682817
- 16701240
- 16713799
- 16713813
- 16716081
- 16738446
- 16746148
- 16754258
- 16754364
- 16759556
- 16773257
- 16774058
- 16774101
- 16774234
- 16782321
- 16800707
- 16806623
- 16806634
- 16806725
- 16814724
- 16830838
- 16841362
- 16841565
- 16845689
- 16854686
- 16873543
- 16882583
- 16883091
- 16889712
- 16899476
- 16911147
- 16914777
- 16918170
- 16918780
- 16923307
- 16940703
- 16944189
- 16948321
- 16952138
- 16952313
- 16977312
- 16981100
- 16981383
- 16981401
- 16985146
- 17001229
- 17005661
- 17010282
- 17010765
- 17010777
- 17033172
- 17035546
- 17040809
- 17041439
- 17045802
- 17063970
- 17064018
- 17080237
- 17085115
- 17085162
- 17108912
- 17109146
- 17109620
- 17112702
- 17121236
- 17139503
- 17139820
- 17147232
- 17150268
- 17150996
- 17174600
- 17175063
- 17175092
- 17175156
- 17178723
- 17185753
- 17185920
- 17189274
- 17189482
- 17189760
- 17200395
- 17200428
- 17200459
- 17209470
- 17209525
- 17232002
- 17235037
- 17235643
- 17235658
- 17239757
- 17251106
- 17258526
- 17258722
- 17258808
- 17258820
- 17275106
- 17289383
- 17289591
- 17289995
- 17294320
- 17310764
- 17325423
- 17325475
- 17327721
- 17327882
- 17341993
- 17345967
- 17346016
- 17353315
- 17353701
- 17369590
- 17369751
- 17378860
- 17378873
- 17378943
- 17390891
- 17391078
- 17391084
- 17408075
- 17408145
- 17420057
- 17420185
- 17430762
- 17431184
- 17431364
- 17449546
- 17456945
- 17469587
- 17473527
- 17473747
- 17496222
- 17500265
- 17511819
- 17521462
- 17525917
- 17541289
- 17545348
- 17545353
- 17551198
- 17551484
- 17576887
- 17608061
- 17608438
- 17608799
- 17614359
REF:B11LT Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar W/Stability Sleeve 11X100MM
- UDI-DI
- 00885825014278
- 16029055
- 16032602
- 16043960
- 16061865
- 16070321
- 16087746
- 16098637
- 16110046
- 16114368
- 16130717
- 16135711
- 16143130
- 16146135
- 16151146
- 16160441
- 16168393
- 16176147
- 16181210
- 16193613
- Lot
- 16193841
- 16197273
- 16210637
- 16225560
- 16234068
- 16243073
- 16255238
- 16270273
- 16281198
- 16288334
- 16294565
- 16297693
- 16298302
- 16330851
- 16331282
- 16343635
- 16347401
- 16371411
- 16371424
- 16388088
- 16403183
- 16403718
- 16414106
- 16427432
- 16431368
- 16447949
- 16467342
- 16477495
- 16487698
- 16494506
- 16500580
- 16508571
- 16521742
- 16532270
- 16535613
- 16535744
- 16548007
- 16555888
- 16570108
- 16574637
- 16587696
- 16587715
- 16590797
- 16599333
- 16599403
- 16604291
- 16608764
- 16623439
- 16633133
- 16645377
- 16651357
- 16652029
- 16655384
- 16665681
- 16674817
- 16675666
- 16705350
- 16705494
- 16713074
- 16716790
- 16721202
- 16729496
- 16745595
- 16746009
- 16759208
- 16763700
- 16774402
- 16778721
- 16793395
- 16796870
- 16806597
- 16813889
- 16818038
- 16826959
- 16830829
- 16841701
- 16845712
- 16850270
- 16854348
- 16864262
- 16873298
- 16882066
- 16890447
- 16910583
- 16911077
- 16918348
- 16932643
- 16932670
- 16944854
- 16948846
- 16954589
- 16954752
- 16960057
- 16973101
- 16997240
- 17001744
- 17028440
- 17028570
- 17031601
- 17041299
- 17049923
- 17059628
- 17066538
- 17076463
- 17088783
- 17095646
- 17109581
- 17113435
- 17135548
- 17139463
- 17150688
- 17151102
- 17169646
- 17170177
- 17204941
- 17205450
- 17209368
- 17209375
- 17227100
- 17251065
- 17254141
- 17263845
- 17271186
- 17271210
- 17281823
- 17294417
- 17299147
- 17322114
- 17328034
- 17341513
- 17368858
- 17390430
- 17403535
- 17403664
- 17403934
- 17425110
- 17429906
- 17449215
- 17469249
- 17473233
- 17481923
- 17505258
- 17505372
- 17526291
- 17540762
- 17551599
- 17565554
- 17581089
- 17596921
- 17608897
- 17609204
- 17623498
- 17630896
- 17655989
- 17669388
- 17688040
- 17691616
REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL Bladeless Trocar W/Optiview Technology & Sleeve 5MM X 75MM
- UDI-DI
- 00885825017231
- 16188647
- 16210212
- 16243934
- 16267300
- 16285639
- 16285656
- 16306188
- 16306231
- 16364978
- 16470903
- 16521533
- 16547722
- 16580202
- 16599810
- 16637989
- 16656930
- 16665550
- 17005619
- 17069758
- Lot
- 17113276
- 17117460
- 17146892
- 17172722
- 17389157
Details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alabama, Alaska, Arizona, Arkansas, California, Colorado, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina , South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming and the countries of Israel and Canada.
- Event ID
- 99634
- Recall numbers
- Z-3182-2026 to Z-3187-2026
- Company
- Stryker Sustainability SolutionsTempe, Arizona
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
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
