FDA recall, , Moderate risk
Swan-Ganz Catheter
Swan-Ganz Catheters may leak or break at the blue proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
Summary by Recall Canary from the FDA notice
What happened
Becton, Dickinson and Company of Irvine, California, began a recall on April 8, 2026, for Swan-Ganz Jr Catheter, Swan-Ganz Pacing Catheter, and Swan-Ganz Catheter products. The catheters may, due to a manufacturing process and material changes, leak or break from the blue proximal injectate lumen hub, which may lead to infection, medication loss, and/or blood loss.
The FDA added the recall to its Enforcement Report on May 15, 2026, with nationwide distribution including all U.S. states and Puerto Rico, as well as worldwide distribution to countries such as Japan, Brazil, and Canada.
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?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Swan-Ganz Jr Catheter, Models: SGPT54, SGPT64P, SGPT755P
- UDI-DI
- 00690103219388
- 65869018
- 66010501
- 67122784
- 00690103219289
- 65956343
- 00690103219371
Swan-Ganz Pacing Catheter, Models: D200F7;
- UDI-DI
- 00690103147315
- 66725358
Swan-Ganz Catheter, Models: 131F7/131F7P, 131F7J, 141F7, 151F7, 834F75, 096F6/096F6P, C144F7, 782F75M, 132F5, C146F7, 831F75/831F75P, TS105F5, 774F75, 777F8, AIQSGF8;
- UDI-DI
- 00690103000412
- 65902900
- 65902901
- 65910728
- 65910729
- 65910730
- 65910731
- 65910732
- 65910735
- 65910736
- 65910737
- 65916927
- 65916928
- 65916929
- 65916930
- 65916931
- 65916932
- 65916933
- 65944791
- 65944792
- 65955857
- 65955858
- 65955859
- 65955860
- 65973739
- 65973740
- 65973741
- 65973742
- 65988571
- 65997478
- 65997479
- 65997481
- 65997482
- 66010504
- 66010505
- 66010506
- 66010507
- 66010508
- 66023074
- 66033088
- 66048930
- 66057629
- 66057630
- 66057944
- 66057945
- 66061552
- 66074999
- 66075318
- 66104892
- 66104893
- 66104894
- 66104895
- 66108277
- 66118638
- 66120310
- 66120312
- 66120313
- 66127027
- 66127028
- 66132570
- 66132571
- 66132572
- 66140447
- 66140448
- 66140449
- 66140450
- 66142269
- 66142274
- 66151008
- 66160820
- 66160821
- 66160822
- 66160823
- 66174935
- 66186389
- 66186390
- 66186391
- 66186393
- 66214346
- 66214347
- 66214348
- 66214349
- 66225263
- 66230833
- 66230834
- 66231174
- 66236300
- 66243301
- 66243302
- 66254697
- 66254698
- 66273573
- 66273574
- 66283862
- 66296222
- 66315689
- 66351811
- 66351812
- 66351813
- 66378395
- 66378396
- 66384489
- 66414674
- 66438179
- 66438197
- 66438198
- 66438199
- 66438200
- 66439368
- 66439369
- 66439370
- 66439371
- 66439372
- 66488597
- 66521743
- 66529338
- 66529339
- 66529340
- 66529341
- 66529345
- 66544240
- 66594945
- 66597237
- 66597238
- 66597239
- 66601166
- 66601167
- 66601168
- 66601169
- 66601170
- 66601171
- 66642726
- 66692566
- 66704724
- 66710839
- 66710840
- 66739812
- 66739813
- 66739814
- 66739910
- 66739911
- 66739912
- 66739913
- 66739916
- 66740114
- 66758828
- 66767282
- 66769651
- 66782067
- 66826029
- 66826030
- 66832079
- 66844048
- 66873884
- 66873885
- 66873886
- 66895223
- 66938771
- 66938772
- 66938773
- 66964710
- 66964711
- 66982688
- 67025469
- 67047800
- 67047801
- 67068446
- 67092101
- 67098252
- 67098253
- 67199591
- 67199595
- 67199596
- 67199617
- 67199618
- 67217934
- 67217935
- 67266297
- 67275624
- 67275626
- 67322713
- 67322714
- 67357488
- 67395549
- 67395555
- 66739917
- 00690103000405
- 67204649
- 67268374
- 00690103000504
- 65891632
- 65891637
- 65916934
- 65916935
- 65944795
- 65955863
- 65973744
- 65988572
- 65997483
- 66023075
- 66023076
- 66033077
- 66061553
- 66273575
- 66315690
- 66378397
- 66414675
- 66414681
- 66465246
- 66552320
- 66594946
- 66623671
- 66644932
- 66739789
- 66767253
- 66809856
- 66809857
- 66812062
- 66826050
- 66873887
- 66945954
- 67014463
- 67056072
- 00690103000566
- 66001841
- 66003074
- 66003075
- 66017563
- 66081903
- 66081904
- 66106780
- 66108265
- 66174936
- 66351108
- 66351109
- 66351111
- 66384522
- 66439364
- 66471244
- 66544241
- 66552321
- 66594947
- 66615747
- 66616064
- 66643585
- 66670993
- 66710846
- 66758827
- 66809858
- 66809859
- 66809860
- 66889370
- 66972526
- 67197204
- 67197205
- 00690103151756
- 66149781
- 66169452
- 66169453
- 66169454
- 66225269
- 66292951
- 66295865
- 66325010
- 66358925
- 66360368
- 66384531
- 66384532
- 66384533
- 66419531
- 66597740
- 66704730
- 66710835
- 66739754
- 66748559
- 66748561
- 66829581
- 66832094
- 66894451
- 66894452
- 66987645
- 67025475
- 67045003
- 67047807
- 67075111
- 67197192
- 67205219
- 00690103000245
- 00690103218602
- 66687312
- 66687922
- 66687924
- 66780053
- 66822159
- 00690103005134
- 66822158
- 00690103197303
- 66725374
- 00690103000467
- 66687936
- 66467271
- 00690103153132
- 00690103003031
- 00690103218282
- 66175089
- 66175090
- 66175091
- 66175092
- 66175093
- 66175094
- 66175095
- 66175096
- 66175097
- 66175103
- 66175104
- 66175105
- 66175120
- 66175121
- 66175122
- 66208306
- 66208323
- 66211381
- 66211385
- 66211386
- 66225264
- 66225265
- 66225266
- 66225267
- 66225268
- 66268847
- 66278675
- 66283844
- 66283845
- 66283846
- 66296223
- 66298719
- 66301299
- 66301300
- 66439365
- 66439366
- 66439367
- 66488586
- 66529347
- 66554378
- 66591113
- 66660610
- 66664653
- 66667556
- 66667557
- 66704725
- 66704758
- 66739799
- 66758829
- 66759128
- 66767284
- 66782068
- 66804400
- 66804401
- 66804402
- 66826032
- 66873891
- 66934651
- 66934677
- 66964714
- 66972587
- 66972588
- 67003703
- 67003704
- 67005151
- 67005156
- 67005540
- 67005541
- 67005542
- 67005543
- 67005544
- 67005545
- 67184885
- 00690103018295
- 00690103146998
- 66521746
- 66844440
- 66844441
- 66844442
- 66844443
- 66844444
- 66844445
- 66844446
- 66844447
- 66844448
- 66844449
- 66844450
- 66844451
- 66844452
- 66844453
- 66919298
- 66919299
- 66920022
- 00690103146554
- 66417428
- 66417429
- 66417430
- 66419577
- 66419578
- 66419579
- 66419580
- 66419581
- 66419582
- 66419583
- 66419584
- 66419585
- 66438181
- 66465249
- 66523321
- 66523328
- 66523330
- 66523331
- 66544242
- 66568201
- 66590392
- 66600645
- 66600646
- 66600647
- 66600648
- 66600649
- 66615750
- 66615751
- 66615752
- 66615753
- 66619148
- 66643587
- 66643588
- 66643589
- 66643590
- 66643591
- 66643592
- 66643593
- 66643594
- 66643595
- 66643596
- 66646363
- 66646364
- 66646365
- 66646366
- 66646367
- 66646368
- 66660611
- 66660612
- 66660613
- 66660614
- 66660615
- 66660616
- 66687707
- 66687708
- 66687805
- 66694839
- 66704726
- 66704727
- 66704728
- 66704729
- 66764452
- 66764453
- 66764454
- 66764455
- 66764456
- 66764457
- 66769776
- 66769777
- 66782069
- 66800668
- 66804171
- 66928758
- 67142955
- 67142972
- 67143094
- 00690103217094
- 66414809
- 66487805
- 66417072
- 66493141
- 66493138
- 66417073
- 66437580
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution including in the states of TX, SC, CT, GA, VA, MO, NM, UT, NJ, CA, FL, PA, IN, TN, WA, KY, MD, WV, MI, MA, NC, MN, NY, AZ, AL, LA, CO, OK, HI, MS, IL, OH, NE, DC, KS, NV, WI, SD, IA, AR, ID, OR, WY, MT, RI, VT, DE, AK, NH, ND, ME, PR and the countries of Japan, Brazil, Colombia, Australia, New Zealand, Poland, Czech Republic, South Africa, Mauritius, Germany, Israel, Iran, Slovakia, Switzerland, Slovenia, Bulgaria, Cyprus, Saudi Arabia, United Arab Emirates (UAE), Kuwait, Malta, Bahrain, Qatar, Hungary, Morocco, Romania, Lebanon, Tunisia, Oman, Turkey, Austria, Belgium, Luxembourg, France, Netherlands, Italy, Spain, Canary Islands, Portugal, United Kingdom, Northern Ireland, Ireland, Denmark, Sweden, Iceland, Norway, Estonia, Finland, Greece, Chile, Puerto Rico, Canada.
- Company
- Becton, Dickinson and CompanyIrvine, California
- Hazard
- Device defect
- 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
- 98603
- Recall numbers
- Z-2202-2026 to Z-2204-2026
All recalls from Becton, Dickinson and Company
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
