FDA recall, May 13, 2026, Moderate risk

Stryker Sustainability Solutions Reprocessed Electrophysiology Catheters

Reprocessed electrophysiology catheters have incomplete seals on sterile product.

Summary by Recall Canary from the FDA notice

Stryker Sustainability Solutions of Tempe, Arizona, recalled reprocessed electrophysiology catheters because of incomplete seals on sterile product. The FDA listed the action in its Enforcement Report on May 13, 2026, after the company began the recall on April 10, 2026. The products were distributed nationwide and to Canada and Israel.

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?

Match the UDI-DI and lot code listed under your product.

Incomplete list: 734 of 6,974 lot codes shown.

A UDI-DI is the device identifier printed with the barcode on the device label.

BARD Dynamic Deca Steerable, Product Number 201101; Reprocessed Electrophysiology Catheter
UDI-DI
00885825003845
Lot code
3021656
4158368
4305347
4457640
4560383
4660045
4815497
4881594
4987017
5032942
3107869
4160047
4305348
4457904
4562726
4660052
4815499
4881600
4987018
5033611
3171909
4160048
4305500
4460044
4565142
4662242
4816776
4881613
4987355
5033612
3197667
4160049
4305998
4461505
4565897
4662243
4816890
4881615
4989058
5033626
BARD Dynamic Tip Steerable, Product Number 6DYNTP001;
UDI-DI
00885825005528
Lot code
3495675
4117216
4330131
4471121
4553575
4630179
4768595
4821705
4954755
5043512
3684287
4129638
4334639
4471122
4554838
4630180
4773075
4821706
4954759
5043513
3691298
4145046
4334644
4474949
4555860
4634858
4793018
4821707
4961661
5043514
3763763
4150788
4334650
4474951
4556028
4634859
4793019
4821708
4971101
5043515
Daig Livewire Steerable, Product Number 401904; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007263
Lot code
3016810
4488621
4592565
4801485
4882673
4967856
4993019
5004980
5043929
5071232
3481897
4488631
4592566
4802770
4882750
4967857
4993023
5005187
5043930
5071390
3625879
4488632
4592567
4804079
4882752
4967858
4993039
5005189
5043931
5071391
3839101
4488634
4592569
4807663
4882753
4968857
4993040
5005332
5043932
5071455
BARD EP XT Decapolar Steerable, Product Number 201007; Reprocessed Electrophysiology Catheter
UDI-DI
00885825003838
Lot code
4225215
4653836
4793147
4852429
4986000
5023873
5043553
4280561
4672798
4799184
4852603
4986001
5023874
5043556
4287896
4677462
4799186
4854910
4986002
5023875
5043560
4296580
4677463
4799187
4856657
4997834
5023876
5053722
4309622
4693434
4799188
4860078
5003556
5027296
5059498
4309623
4693435
4799191
4860082
5003557
Daig Livewire Steerable, Product Number 401581; Reprocessed Electrophysiology Catheter
UDI-DI
00885825006877
Lot code
3683857
3836878
3981321
4042778
4053585
4103495
4496897
3683858
3891551
3991434
4052721
4053586
4111212
4496898
3694871
3932470
3991439
4052723
4103479
4111213
4549309
3762375
3942462
3991442
4052726
4103480
4111214
4549312
3764605
3964790
3991444
4052727
4103481
4111216
4570926
3764606
3971860
3991445
4052735
4103482
BARD Dynamic Tip Steerable, Product Number 200344; Reprocessed Electrophysiology Catheter
UDI-DI
00885825003135
Lot code
2268964
2687510
3173767
3269330
3379246
4398753
4876242
2501717
2878890
3231930
3336473
3394078
4780878
4876243
2533915
3137651
3266358
3361335
3454810
4821709
Daig Livewire Steerable, Product Number 401915; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007300
Lot code
1772607
3994138
4539200
4808444
4985924
5010522
5042942
2482952
4046485
4539206
4808677
4986242
5010524
5042944
2521570
4164020
4540476
4812775
4986243
5017909
5042945
2521636
4166570
4544644
4817888
4986244
5018848
5043881
2521660
4182322
4549452
4824089
4986245
5020135
5043883
2577590
4183176
4549458
4824092
4986256
Daig Livewire Steerable, Product Number 401905; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007270
Lot code
4026564
4229299
4801695
4953879
4987354
5020148
5075816
4062382
4229325
4820358
4953880
4993906
5034504
5075889
4126798
4274291
4821138
4953881
4993907
5034505
5075890
4133063
4294908
4835292
4953882
4993909
5044394
5075900
4159795
4393599
4841302
4972396
4993911
5044402
5075908
4185728
4487172
4842791
4972397
4998472
CS Uni-Directional w Auto ID, Product Number D135304; Reprocessed Electrophysiology Catheter
UDI-DI
07613327357318
Lot code
3351120
4756053
4820613
4880639
4937971
4953195
4974710
5002528
5033775
5067727
3351123
4761288
4821747
4880648
4937973
4953196
4975470
5002529
5033776
5069585
3352961
4764911
4821750
4880654
4937974
4953197
4975472
5002530
5034566
5069588
3369921
4766954
4822911
4880655
4937975
4953198
4975598
5002531
5034567
5069594
Daig Livewire Steerable BDB, Product Number 401918, Reprocessed Electrophysiology Catheter
UDI-DI
00885825007324
Lot code
4101996
4175347

Show the other 16 products

BW Webster Duo-Decapolar, Product Number D728260RT; Reprocessed Electrophysiology Catheter
UDI-DI
00885825011529
Lot code
3881385
4808385
4854113
4961672
4974217
4988584
4993237
5016458
5021634
5048549
3921444
4822971
4945780
4961673
4979107
4988587
4994122
5016460
5021635
5050589
3998693
4822986
4945781
4961674
4981313
4988751
4994128
5016461
5021636
5053395
4029481
4822987
4953683
4970070
4982419
4988752
4994180
5016462
5021637
5053396
Daig Livewire Steerable, Product Number 401914; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007294
Lot code
3293805
4060170
4533158
4613654
4678077
4846998
4973532
4976226
5005455
5056648
BARD Dynamic XT Steerable, Product Number 201104; Reprocessed Electrophysiology Catheter
UDI-DI
00885825003890
Lot code
4064760
4336810
4381356
4381359
4401919
Daig Livewire Steerable, Product Number 401603, Reprocessed Electrophysiology Catheter
UDI-DI
00885825006969
Lot code
3978113
4465650
4468623
4594989
4622932
4622934
4629627
4665006
4720693
Medtronic Marinr Steerable, Product Number 72402; Reprocessed Electrophysiology Catheter
Lot code
4147881
4760091
4848398
4966192
4995002
5022496
5053580
4470118
4778468
4848976
4966193
4999115
5029362
5063586
4490754
4796800
4855294
4966194
5002565
5029363
5068369
4509009
4815121
4866012
4966195
5002566
5029364
5076464
4527883
4815122
4874149
4969132
5002873
5029535
5085337
4655115
4820151
4883354
4973129
5009392
Daig Livewire Steerable, Product Number 401582; Reprocessed Electrophysiology Catheter
UDI-DI
00885825006884
Lot code
3002664
4092049
4580888
4627994
4778840
4860529
4998452
4026540
4098358
4620256
4627999
4813542
4985859
4072508
4498128
4620257
4755333
4860528
4985861
Daig Livewire Steerable, Product Number 401575; Reprocessed Electrophysiology Catheter
UDI-DI
00885825006815
Lot code
2696145
3794476
4262195
4633829
4786916
4849947
5002352
2965551
3812493
4265992
4637189
4792723
4850691
5002356
3152561
3814730
4299204
4637394
4792893
4851631
5002359
3172403
3816485
4337701
4638269
4793417
4851632
5002471
3214127
3851379
4337958
4639992
4793418
4851633
5002472
3229881
3851380
4345121
4640104
4794109
Daig Livewire Steerable, Product Number 401652; Reprocessed Electrophysiology Catheter
UDI-DI
00885825006983
Lot code
3430230
4648604
4945422
4999751
5044134
5059493
4454505
4882788
4950218
4999755
5044135
5086419
4454517
4945388
4993562
5044132
5044136
5086420
4648603
4945405
4993565
5044133
5044137
CS Uni-Directional w Auto ID, Product Number D135303; Reprocessed Electrophysiology Catheter
UDI-DI
07613327357301
Lot code
2934107
3695884
3813841
3963557
4293648
4660245
4816422
4937844
4984006
5024442
2964378
3695885
3813842
3963558
4294641
4665924
4816423
4937846
4984751
5024443
3369649
3695886
3813843
3963559
4320451
4665926
4820652
4937850
4985810
5025866
3414030
3695889
3813844
3963561
4320454
4677505
4824140
4937853
4985813
5025908
BARD Dynamic XT Steerable, Product Number 201103, Reprocessed Electrophysiology Catheter
UDI-DI
00885825003876
Daig Livewire Steerable, Product Number 401923; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007331
Lot code
3557411
3702628
4498116
BARD Dynamic XT Deca Steerable, Product Number 201102, Reprocessed Electrophysiology Catheter
UDI-DI
00885825003869
Lot code
3975235
4253785
4277547
4297459
4656095
4818154
4972266
4065815
4253786
4277548
4297460
4656096
4818155
5032390
4180953
4253791
4296975
4363237
4717623
4818156
5032392
4223973
4254918
4296977
4404427
4717624
4831929
5032393
4253773
4254919
4296978
4481136
4717625
4831931
5032394
4253774
4254921
4296979
4494845
4742015
Daig Livewire Steerable, Product Number 401908; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007287
Lot code
3459566
3623281
4191726
Daig Livewire Steerable, Product Number 401932; Reprocessed Electrophysiology Catheter
UDI-DI
00885825007355
Lot code
4248065
4625922
4792899
4880229
4947722
4982083
5004927
5022043
5031874
5063926
4253253
4642049
4798611
4880230
4950352
4982089
5004930
5022044
5032223
5063929
4253255
4643022
4804375
4880231
4950943
4982090
5008468
5022045
5032225
5063931
4282439
4650872
4804411
4880233
4950945
4982091
5008470
5022046
5032226
5063932
BARD Dynamic Tip Steerable, Product Number 200131; Reprocessed Electrophysiology Catheter
UDI-DI
00885825002930
Lot code
3966097
4314254
4490535
4511367
4517632
4607771
4762688
4056491
4401626
4490540
4511368
4567842
4628229
4775309
4137164
4455383
4490542
4511369
4567844
4628232
4875058
4154024
4463033
4490544
4511370
4567866
4628234
5023284
4165178
4472622
4495807
4511372
4567888
4628242
5023285
4250497
4490533
4502016
4511375
4567898
BARD EP XT Steerable, Product Number 200794; Reprocessed Electrophysiology Catheter
UDI-DI
00885825003739
Lot code
4573219
4869696
4992244
4999900
5025367
5038410
5085389
4804556
4971805
4992245
4999902
5032111
5043783
4804558
4971806
4992246
5012684
5032112
5043784
4809474
4990763
4992247
5012708
5032113
5043785
4829451
4990764
4993772
5012709
5033926
5043787
4835199
4990769
4997966
5012711
5033927
5056579
4841812
4992243
4998135

Recall details

Company began the recall

Apr 10, 2026

Sold in

US Nationwide and the countries of Israel and Canada.

Company

Stryker Sustainability SolutionsTempe, Arizona

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

98708

Recall numbers

Z-2174-2026 to Z-2199-2026

All recalls from Stryker Sustainability Solutions

Timeline

FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.

Apr 10, 2026
Company began the recall
May 13, 2026
Added to FDA's Enforcement Report · Classified by FDA
May 14, 2026
Listed on Recall Canary
May 20, 2026
In FDA's weekly enforcement report
Oct 3, 2026
Summary updated

What happened

What to do

Is yours affected?

BARD Dynamic Deca Steerable, Product Number 201101; Reprocessed Electrophysiology Catheter

BARD Dynamic Tip Steerable, Product Number 6DYNTP001;

Daig Livewire Steerable, Product Number 401904; Reprocessed Electrophysiology Catheter

BARD EP XT Decapolar Steerable, Product Number 201007; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401581; Reprocessed Electrophysiology Catheter

BARD Dynamic Tip Steerable, Product Number 200344; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401915; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401905; Reprocessed Electrophysiology Catheter

CS Uni-Directional w Auto ID, Product Number D135304; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable BDB, Product Number 401918, Reprocessed Electrophysiology Catheter

BW Webster Duo-Decapolar, Product Number D728260RT; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401914; Reprocessed Electrophysiology Catheter

BARD Dynamic XT Steerable, Product Number 201104; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401603, Reprocessed Electrophysiology Catheter

Medtronic Marinr Steerable, Product Number 72402; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401582; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401575; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401652; Reprocessed Electrophysiology Catheter

CS Uni-Directional w Auto ID, Product Number D135303; Reprocessed Electrophysiology Catheter

BARD Dynamic XT Steerable, Product Number 201103, Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401923; Reprocessed Electrophysiology Catheter

BARD Dynamic XT Deca Steerable, Product Number 201102, Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401908; Reprocessed Electrophysiology Catheter

Daig Livewire Steerable, Product Number 401932; Reprocessed Electrophysiology Catheter

BARD Dynamic Tip Steerable, Product Number 200131; Reprocessed Electrophysiology Catheter

BARD EP XT Steerable, Product Number 200794; Reprocessed Electrophysiology Catheter

Recall details

Timeline

Same product, other recalls

Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter