FDA recall, , Moderate risk
Boston Scientific CRE and CRE Pro Wireguided Balloon Dilators
Potential sterile breach of the pouches in which devices are packaged.
Summary by Recall Canary from the FDA notice
What happened
Boston Scientific Corporation is recalling CRE Pro Wireguided and CRE Wireguided devices after the FDA identified a potential sterile breach of the pouches in which devices are packaged. The recall began May 21, 2026, and was added to the FDA's Enforcement Report on July 1, 2026. Distribution is nationwide and worldwide, including countries such as Australia, Canada, Germany, Japan, and the United States.
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.
Incomplete list: 280 of 796 lot codes shown.
A UDI-DI is the device identifier printed with the barcode on the device label.
CRE Pro Wireguided 12-15mm 240cm
- UDI-DI
- 8714729797579
- 38031635
- 38031636
- 38031637
- 38031638
- 38031639
- 38031640
- 38031641
- 38043114
- 38043115
- 38053614
- 38053615
- 38053616
- 38078354
- 38188253
- 38200578
- 38211780
- 38214898
- 38214899
- 38222485
- 38222487
- 38241871
- 38241872
- 38267022
- 38267023
- 38267024
- 38267025
- 38267026
- 38267027
- 38267028
- 38269136
- 38269137
- 38269138
- 38277754
- 38277755
- 38278152
- 38278153
- 38278154
- 38285222
- 38285223
- 38293322
- 38293324
- 38293325
- 38293326
- 38293327
- 38293328
- 38293329
- 38303877
- 38303878
- 38320463
- 38346663
- 38346664
- 38346681
- 38347329
- 38378376
- 38379273
- 38379917
- 38379918
- 38379919
- 38380040
- 38380041
- 38380042
- 38383937
- 38383938
- 38383939
- 38383980
- 38383981
- 38383982
- 38383983
- 38383984
- 38398522
- 38414085
- 38414086
- 38414087
- 38414088
- 38414089
- 38414090
- 38414091
- 38414092
- 38445939
- 38446200
- 38446201
- 38446202
- 38446203
- 38446216
- 38479982
- 38479983
- 38479984
- 38479985
- 38479986
- 38507316
- 38507317
- 38507318
- 38507319
- 38507560
- 38529186
- 38529188
- 38529189
- 38529191
- 38529193
- 38529194
- 38529195
- 38529197
- 38529198
- 38529199
- 38529380
- 38529381
- 38529383
- 38529384
- 38570828
- 38570829
- 38570830
- 38589819
- 38672653
- 38672654
- 38672655
- 38726668
- 38726669
- 38726670
- 38726671
- 38726672
- 38726673
- 38726674
- 38726675
- 38734732
- 38734733
- 38734735
- 38748256
- 38748257
- 38748258
- 38748259
- 38748401
- 38800521
- 38800522
- 38800523
- 38827801
- 38827802
- 38827803
- 38827804
- 38827805
- 38827806
- 38831789
- 38831790
- 38831791
- 38831792
- 38847493
- 38847494
- 38847495
- 38847496
- 38847497
- 38847498
- 38847499
- 38847680
- 38847681
- 38878813
- 38878814
- 38878815
- 38878816
- 38878817
- 38878818
- 38886480
- 38886481
- 38916787
- 38916788
- 38916789
- 38916790
- 38933953
- 38933954
- 38933955
- 38933956
- Lot code
- 38031635
- 38031636
- 38031637
- 38031638
- 38031639
- 38031640
- 38031641
- 38043114
- 38043115
- 38053614
- 38053615
- 38053616
- 38078354
- 38188253
- 38200578
- 38211780
- 38214898
- 38214899
- 38222485
- 38222487
- 38241871
- 38241872
- 38267022
- 38267023
- 38267024
- 38267025
- 38267026
- 38267027
- 38267028
- 38269136
- 38269137
- 38269138
- 38277754
- 38277755
- 38278152
- 38278153
- 38278154
- 38285222
- 38285223
- 38293322
CRE Pro Wireguided 10-12mm 240cm
- UDI-DI
- 8714729797562
- 38031620
- 38031621
- 38031622
- 38031623
- 38031624
- 38031625
- 38031626
- 38031627
- 38031628
- 38031629
- 38031631
- 38075353
- 38078357
- 38078358
- 38078359
- 38078740
- 38078741
- 38078742
- 38078743
- 38078744
- 38078745
- 38078747
- 38100058
- 38100717
- 38100718
- 38118422
- 38118423
- 38118424
- 38118425
- 38118426
- 38118427
- 38139132
- 38139133
- 38162877
- 38164341
- 38169205
- 38169206
- 38172338
- 38176726
- 38176727
- 38187282
- 38187283
- 38193521
- 38238865
- 38304060
- 38304061
- 38304062
- 38304063
- 38304064
- 38306688
- 38334070
- 38334071
- 38334072
- 38334073
- 38383986
- 38398490
- 38398491
- 38398492
- 38402798
- 38402799
- 38403020
- 38403021
- 38421915
- 38421916
- 38421917
- 38421918
- 38421919
- 38450264
- 38450265
- 38450266
- 38450267
- 38450268
- 38450269
- 38450270
- 38468759
- 38507309
- 38507310
- 38507311
- 38507312
- 38507313
- 38507314
- 38515209
- 38515210
- 38552614
- 38552615
- 38552616
- 38552617
- 38552618
- 38552619
- 38553520
- 38553521
- 38553522
- 38578999
- 38579280
- 38579284
- 38579285
- 38608100
- 38612264
- 38612265
- 38612266
- 38622468
- 38622469
- 38622470
- 38622471
- 38622472
- 38622473
- 38650479
- 38650820
- 38650821
- 38666087
- 38668807
- 38678761
- 38678762
- 38689027
- 38689034
- 38690516
- 38745675
- 38745676
- 38769693
- 38769694
- 38769695
- 38800516
- 38800517
- 38800518
- 38800519
- 38864609
- 38864610
- 38864611
- 38864720
- 38886482
- 38886483
- 38886484
- 38906032
- 38906033
- 38906034
- 38906035
- 38916791
- 38916792
- 38933950
- 38933951
- 38933952
- 38958793
- 38959787
- 38959788
- Lot code
- 38031620
- 38031621
- 38031622
- 38031623
- 38031624
- 38031625
- 38031626
- 38031627
- 38031628
- 38031629
- 38031631
- 38075353
- 38078357
- 38078358
- 38078359
- 38078740
- 38078741
- 38078742
- 38078743
- 38078744
- 38078745
- 38078747
- 38100058
- 38100717
- 38100718
- 38118422
- 38118423
- 38118424
- 38118425
- 38118426
- 38118427
- 38139132
- 38139133
- 38162877
- 38164341
- 38169205
- 38169206
- 38172338
- 38176726
- 38176727
CRE Pro Wireguided 15-18mm 240cm
- UDI-DI
- 8714729797586
- 38043116
- 38192116
- 38192117
- 38192118
- 38192119
- 38192960
- 38192961
- 38214896
- 38214897
- 38222153
- 38222496
- 38222497
- 38222498
- 38222499
- 38222660
- 38222661
- 38222662
- 38222663
- 38222664
- 38222665
- 38238864
- 38239084
- 38239085
- 38239086
- 38239087
- 38239088
- 38239089
- 38241874
- 38241875
- 38241876
- 38242679
- 38242820
- 38242821
- 38242822
- 38242824
- 38269134
- 38269135
- 38274558
- 38274559
- 38282412
- 38324631
- 38324632
- 38324633
- 38324634
- 38324636
- 38324637
- 38324638
- 38347325
- 38347326
- 38347327
- 38347328
- 38364300
- 38381887
- 38421906
- 38421907
- 38421908
- 38421909
- 38421910
- 38421911
- 38421912
- 38421913
- 38421914
- 38441933
- 38441934
- 38441935
- 38441936
- 38450077
- 38450078
- 38450079
- 38450260
- 38450261
- 38450262
- 38450263
- 38462131
- 38462132
- 38462133
- 38468755
- 38468756
- 38472371
- 38472372
- 38472373
- 38479757
- 38479758
- 38503030
- 38507563
- 38507564
- 38507565
- 38507566
- 38507567
- 38507568
- 38507569
- 38568778
- 38568779
- 38568860
- 38585010
- 38585011
- 38585012
- 38585013
- 38621957
- 38621958
- 38642724
- 38642725
- 38642726
- 38642727
- 38665032
- 38665033
- 38665034
- 38665035
- 38665036
- 38665038
- 38678315
- 38688161
- 38726662
- 38726663
- 38726664
- 38734730
- 38734731
- 38745591
- 38748249
- 38748250
- 38748251
- 38748253
- 38762224
- 38762225
- 38762226
- 38762227
- 38762228
- 38769690
- 38769691
- 38769692
- 38800533
- 38800534
- 38800535
- 38800536
- 38831782
- 38831783
- 38831784
- 38831785
- 38831786
- 38831787
- 38831788
- 38877007
- 38877008
- 38877009
- 38878807
- 38878808
- 38878809
- 38878810
- 38878811
- 38878812
- 38886257
- 38886258
- 38886259
- 38916782
- 38916783
- 38916784
- 38916785
- 38933957
- 38933958
- 38933959
- 38935360
- 38945672
- Lot code
- 38043116
- 38192116
- 38192117
- 38192118
- 38192119
- 38192960
- 38192961
- 38214896
- 38214897
- 38222153
- 38222496
- 38222497
- 38222498
- 38222499
- 38222660
- 38222661
- 38222662
- 38222663
- 38222664
- 38222665
- 38238864
- 38239084
- 38239085
- 38239086
- 38239087
- 38239088
- 38239089
- 38241874
- 38241875
- 38241876
- 38242679
- 38242820
- 38242821
- 38242822
- 38242824
- 38269134
- 38269135
- 38274558
- 38274559
- 38282412
CRE Pro Wireguided 6-8mm 240cm
- UDI-DI
- 8714729797548
- 38031492
- 38031493
- 38031494
- 38075351
- 38078758
- 38078759
- 38130599
- 38131540
- 38131541
- 38162878
- 38187284
- 38187285
- 38204694
- 38204695
- 38204696
- 38380212
- 38380333
- 38408115
- 38408116
- 38408117
- 38408118
- 38608097
- 38622221
- 38642730
- 38678313
- 38693569
- 38770151
- 38770152
- 38864607
- 38864608
- 38906029
- 38933949
- 38960096
CRE Wireguided 8-10mm 240cm
- UDI-DI
- 8714729339397
- 38064055
- 38099717
- 38100033
- 38100034
- 38164759
- 38165000
- 38165003
- 38293337
- 38293338
- 38293339
- 38333957
- 38347335
- 38347336
- 38398764
- 38398765
- 38398766
- 38529517
- 38552112
- 38552113
- 38596880
- 38680056
- 38680057
- 38739675
CRE Wireguided 15-18mm 240cm
- UDI-DI
- 8714729339427
- 38033568
- 38033569
- 38033570
- 38033571
- 38047498
- 38047722
- 38047731
- 38200167
- 38239090
- 38325015
- 38325016
- 38325017
- 38413205
- 38413206
- 38413207
- 38413208
- 38413214
- 38422540
- 38422541
- 38422542
- 38422543
- 38479759
- 38507303
- 38507304
- 38519497
- 38519498
- 38529540
- 38529541
- 38529542
- 38529543
- 38529544
- 38585005
- 38585006
- 38647771
- 38790079
- 38817673
- 38817674
- 38817675
- 38817676
- 38817677
- 38817678
- 38817679
- Lot code
- 38033568
- 38033569
- 38033570
- 38033571
- 38047498
- 38047722
- 38047731
- 38200167
- 38239090
- 38325015
- 38325016
- 38325017
- 38413205
- 38413206
- 38413207
- 38413208
- 38413214
- 38422540
- 38422541
- 38422542
- 38422543
- 38479759
- 38507303
- 38507304
- 38519497
- 38519498
- 38529540
- 38529541
- 38529542
- 38529543
- 38529544
- 38585005
- 38585006
- 38647771
- 38790079
- 38817673
- 38817674
- 38817675
- 38817676
- 38817677
CRE Wireguided 12-15mm 240cm
- UDI-DI
- 8714729339410
- 38033567
- 38056239
- 38056940
- 38056941
- 38215260
- 38266854
- 38266855
- 38293330
- 38391881
- 38413876
- 38413877
- 38413878
- 38413879
- 38414080
- 38422547
- 38446204
- 38466097
- 38468862
- 38468863
- 38529518
- 38529519
- 38585004
- 38622477
- 38622478
- 38640994
- 38670501
- 38670502
- 38670504
- 38686282
- 38686283
- 38693725
- 38726666
- 38726667
- 38748254
- 38767487
- 38789996
- 38800181
- 38879160
- 38879163
- 38879164
- 38911928
- 38911929
- 38911930
- 38944841
- Lot code
- 38033567
- 38056239
- 38056940
- 38056941
- 38215260
- 38266854
- 38266855
- 38293330
- 38391881
- 38413876
- 38413877
- 38413878
- 38413879
- 38414080
- 38422547
- 38446204
- 38466097
- 38468862
- 38468863
- 38529518
- 38529519
- 38585004
- 38622477
- 38622478
- 38640994
- 38670501
- 38670502
- 38670504
- 38686282
- 38686283
- 38693725
- 38726666
- 38726667
- 38748254
- 38767487
- 38789996
- 38800181
- 38879160
- 38879163
- 38879164
CRE Wireguided 6-8mm 240cm
- UDI-DI
- 8714729339380
- 38064056
- 38064057
- 38200574
- 38200575
- 38204501
- 38204504
- 38204506
- 38204508
- 38628161
- 38640993
- 38767490
- 38904960
- 38904961
- 38946757
- 38946758
- 38946759
CRE Wireguided 18-20mm 240cm
- UDI-DI
- 8714729339434
- 38033572
- 38063250
- 38063251
- 38063252
- 38211783
- 38211784
- 38215261
- 38215262
- 38215263
- 38222236
- 38222237
- 38222238
- 38222239
- 38241879
- 38242360
- 38242361
- 38334062
- 38334063
- 38347338
- 38468864
- 38472364
- 38472365
- 38479755
- 38596733
- 38596734
- 38596735
- 38596736
- 38596883
- 38596884
- 38692526
- 38707831
- 38709738
- 38709739
- 38748244
- 38808896
- 38874312
- 38874313
- 38874314
- 38886248
- 38886249
CRE Pro Wireguided 8-10mm 240cm
- UDI-DI
- 8714729797555
- 38031497
- 38031499
- 38067106
- 38067107
- 38067108
- 38075352
- 38077694
- 38078752
- 38078753
- 38078754
- 38078756
- 38110982
- 38131542
- 38131543
- 38131544
- 38162876
- 38169207
- 38174433
- 38176724
- 38176725
- 38176728
- 38176729
- 38200576
- 38200577
- 38212061
- 38240328
- 38285224
- 38297438
- 38297439
- 38297800
- 38297801
- 38306683
- 38306684
- 38357962
- 38357963
- 38357964
- 38357965
- 38357966
- 38357967
- 38371552
- 38381888
- 38398493
- 38400165
- 38437963
- 38468757
- 38468758
- 38468861
- 38507306
- 38507307
- 38552610
- 38552611
- 38552612
- 38552613
- 38568865
- 38568866
- 38568867
- 38579282
- 38579283
- 38591247
- 38598328
- 38598329
- 38598330
- 38622433
- 38622434
- 38622435
- 38650822
- 38690511
- 38690512
- 38697220
- 38697221
- 38747993
- 38747994
- 38770143
- 38770144
- 38770145
- 38770146
- 38770147
- 38770148
- 38770149
- 38770150
- 38886485
- 38886486
- 38886487
- 38934882
- 38958333
- 38960098
- 38960099
- 38970337
- Lot code
- 38031497
- 38031499
- 38067106
- 38067107
- 38067108
- 38075352
- 38077694
- 38078752
- 38078753
- 38078754
- 38078756
- 38110982
- 38131542
- 38131543
- 38131544
- 38162876
- 38169207
- 38174433
- 38176724
- 38176725
- 38176728
- 38176729
- 38200576
- 38200577
- 38212061
- 38240328
- 38285224
- 38297438
- 38297439
- 38297800
- 38297801
- 38306683
- 38306684
- 38357962
- 38357963
- 38357964
- 38357965
- 38357966
- 38357967
- 38371552
CRE Wireguided 10-12mm 240cm
- UDI-DI
- 8714729339403
- 38099718
- 38165001
- 38165002
- 38196568
- 38196569
- 38196570
- 38204511
- 38204512
- 38204513
- 38285933
- 38397792
- 38398767
- 38398768
- 38507308
- 38552115
- 38596881
- 38596882
- 38612829
- 38612830
- 38680058
- 38683384
- 38683385
- 38689434
- 38690171
- 38707829
- 38707830
- 38710480
- 38769697
- 38800182
- 38800183
- 38871161
- 38871162
- 38871163
- 38937571
CRE Pro Wireguided 18-20mm 240cm
- UDI-DI
- 8714729797593
- 38031485
- 38031486
- 38031487
- 38031488
- 38031489
- 38031490
- 38031642
- 38031643
- 38031644
- 38031645
- 38043600
- 38043601
- 38043602
- 38043603
- 38043604
- 38055580
- 38055581
- 38055582
- 38099704
- 38099705
- 38099706
- 38099707
- 38099709
- 38099710
- 38099711
- 38099712
- 38099713
- 38099714
- 38099715
- 38110376
- 38110377
- 38110378
- 38110379
- 38131547
- 38131548
- 38150880
- 38150881
- 38150882
- 38150883
- 38162872
- 38162873
- 38162874
- 38162875
- 38169202
- 38169203
- 38193520
- 38241877
- 38241878
- 38258885
- 38258886
- 38258887
- 38258888
- 38258889
- 38278151
- 38285220
- 38285221
- 38306689
- 38306692
- 38338285
- 38338288
- 38338290
- 38338292
- 38338294
- 38338296
- 38338297
- 38338299
- 38338301
- 38347330
- 38462126
- 38462127
- 38462128
- 38462129
- 38479753
- 38479754
- 38553523
- 38553524
- 38553525
- 38608098
- 38608099
- 38612875
- 38612876
- 38612877
- 38612878
- 38622479
- 38622600
- 38622601
- 38622602
- 38622603
- 38642700
- 38642701
- 38642702
- 38642722
- 38650472
- 38665039
- 38665260
- 38665261
- 38665262
- 38665263
- 38678316
- 38678317
- 38678318
- 38678319
- 38678760
- 38702327
- 38702328
- 38702329
- 38702330
- 38702331
- 38702332
- 38709525
- 38709526
- 38709527
- 38709528
- 38734736
- 38742717
- 38742718
- 38745588
- 38745589
- 38745590
- 38748246
- 38748247
- 38748248
- 38808893
- 38808894
- 38808897
- 38808899
- 38809140
- 38823455
- 38823456
- 38823457
- 38874308
- 38874309
- 38874310
- 38874311
- 38877005
- 38877006
- 38886252
- 38886253
- 38886254
- 38886255
- 38946205
- 38946207
- 38946209
- 38959786
- 38964092
- 38964093
- Lot code
- 38031485
- 38031486
- 38031487
- 38031488
- 38031489
- 38031490
- 38031642
- 38031643
- 38031644
- 38031645
- 38043600
- 38043601
- 38043602
- 38043603
- 38043604
- 38055580
- 38055581
- 38055582
- 38099704
- 38099705
- 38099706
- 38099707
- 38099709
- 38099710
- 38099711
- 38099712
- 38099713
- 38099714
- 38099715
- 38110376
- 38110377
- 38110378
- 38110379
- 38131547
- 38131548
- 38150880
- 38150881
- 38150882
- 38150883
- 38162872
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the countries of Australia, Austria, Bahrain, Bangladesh, Belgium, Bulgaria, Canada, Chile, China, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Great Britain, Greece, Guatemala, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Mongolia, Netherlands, New Zealand, Norway, Pakistan, Paraguay, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Tobago, Trinidad, Tunisia, T¿rkiye, United Arab Emirates, Uruguay.
- Company
- Boston Scientific CorporationMarlborough, Massachusetts
- 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
- 99067
- Recall numbers
- Z-2626-2026 to Z-2637-2026
All recalls from Boston Scientific 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
