FDA recall, , Moderate risk
Stryker Sustainability Solution Color Cuff
The tourniquet cuffs can detach from the bladder at the welding connection.
Summary by Recall Canary from the FDA notice
What happened
Stryker Sustainability Solutions, based in Tempe, Arizona, began a recall on March 12, 2026, of certain tourniquet cuffs because the cuffs can detach from the bladder at the welding connection, which could result in the cuff not being able to maintain pressure.
The recalled products include the Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235, the Color Cuff 18" (Red) Quick Connect Dual Port Single Bladder REF 5921-018-135, and the Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
The recall involves 56,740 cuffs and was added to the FDA's Enforcement Report on April 9, 2026. The cuffs were distributed in the United States across numerous states and the District of Columbia. The FDA classified the recall on April 9, 2026, and it was included in the FDA's weekly enforcement report on April 15, 2026.
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?
Compare the details below with your product and check the FDA notice to confirm whether it is affected.
A UDI-DI is the device identifier printed with the barcode on the device label.
Product details
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
- UDI-DI
- 50885825016024
- 0000608407
- 0000666479
- 0000710705
- 0000748402
- 0000779936
- 0000806234
- 0000823124
- 0000853520
- 0001026721
- 0001191140
- 0000610592
- 0000668978
- 0000713274
- 0000750469
- 0000782278
- 0000806424
- 0000823125
- 0000856167
- 0001028153
- 0001204019
- 0000613383
- 0000674814
- 0000716919
- 0000753840
- 0000784288
- 0000807132
- 0000824757
- 0000877820
- 0001033211
- 0001217956
- 0000618222
- 0000679061
- 0000720023
- 0000754633
- 0000787628
- 0000808365
- 0000827488
- 0000878368
- 0001058134
- 0001229508
- 0000628325
- 0000680520
- 0000720933
- 0000755710
- 0000788773
- 0000809629
- 0000829817
- 0000884047
- 0001072723
- 0001231688
- 0000634780
- 0000683417
- 0000726263
- 0000756541
- 0000790106
- 0000811248
- 0000831661
- 0000887355
- 0001080285
- 0001238396
- 0000645259
- 0000687976
- 0000729862
- 0000757389
- 0000790446
- 0000811740
- 0000832427
- 0000899094
- 0001087139
- 0001247960
- 0000647073
- 0000689032
- 0000734825
- 0000759043
- 0000792153
- 0000813049
- 0000833383
- 0000904725
- 0001107907
- 0001248642
- 0000649426
- 0000690670
- 0000736903
- 0000766311
- 0000793178
- 0000813414
- 0000839160
- 0000936850
- 0001109580
- 0000650589
- 0000694958
- 0000740521
- 0000770116
- 0000795030
- 0000816441
- 0000842177
- 0000950419
- 0001117732
- 0000650994
- 0000696012
- 0000741830
- 0000771335
- 0000795826
- 0000818289
- 0000843424
- 0000956337
- 0001118566
- 0000652336
- 0000697626
- 0000742683
- 0000773128
- 0000796587
- 0000819853
- 0000846088
- 0000973851
- 0001158477
- 0000658811
- 0000699733
- 0000745094
- 0000775812
- 0000800461
- 0000820677
- 0000848208
- 0000982970
- 0001163184
- 0000662208
- 0000704540
- 0000746765
- 0000777690
- 0000801547
- 0000821695
- 0000850631
- 0000997622
- 0001171995
- 0000663506
- 0000705054
- 0000747787
- 0000778370
- 0000804320
- 0000822757
- 0000852419
- 0001012102
- 0001188671
- 50885825016062
- 0000609899
- 0000650590
- 0000690671
- 0000726264
- 0000763461
- 0000792154
- 0000816443
- 0000840363
- 0001012101
- 0001171996
- 0000610593
- 0000658812
- 0000695297
- 0000727476
- 0000768855
- 0000792752
- 0000818286
- 0000842180
- 0001026722
- 0001188678
- 0000613711
- 0000662209
- 0000696013
- 0000732858
- 0000771336
- 0000795827
- 0000821298
- 0000844327
- 0001029500
- 0001200103
- 0000623945
- 0000666480
- 0000696720
- 0000739438
- 0000773129
- 0000796588
- 0000822852
- 0000846560
- 0001047460
- 0001229509
- 0000626120
- 0000669025
- 0000697627
- 0000740445
- 0000777026
- 0000799105
- 0000826220
- 0000854710
- 0001066338
- 0001247961
- 0000633577
- 0000674643
- 0000703467
- 0000741831
- 0000779645
- 0000802579
- 0000826374
- 0000876426
- 0001079442
- 0001253084
- 0000636292
- 0000675503
- 0000706848
- 0000744953
- 0000783272
- 0000806235
- 0000829318
- 0000888999
- 0001087140
- 0001254940
- 0000638716
- 0000679066
- 0000709328
- 0000751420
- 0000785086
- 0000808363
- 0000829844
- 0000915425
- 0001107908
- 0001259581
- 0000643088
- 0000681303
- 0000712558
- 0000754295
- 0000787957
- 0000809212
- 0000831758
- 0000936775
- 0001114240
- 0000645991
- 0000683427
- 0000717160
- 0000755547
- 0000789793
- 0000812544
- 0000833100
- 0000949315
- 0001118567
- 0000647074
- 0000687285
- 0000720024
- 0000757390
- 0000790107
- 0000815929
- 0000838765
- 0000988077
- 0001158473
- 50885825016116
- 0000609378
- 0000658814
- 0000700579
- 0000745097
- 0000782284
- 0000808367
- 0000832426
- 0000889000
- 0001012100
- 0001204021
- 0000610595
- 0000663505
- 0000703816
- 0000746163
- 0000783274
- 0000809214
- 0000832864
- 0000891969
- 0001026723
- 0001218006
- 0000611745
- 0000667625
- 0000705436
- 0000748057
- 0000785984
- 0000811249
- 0000835176
- 0000900056
- 0001028154
- 0001222644
- 0000614822
- 0000672680
- 0000708327
- 0000749928
- 0000786744
- 0000812293
- 0000838774
- 0000906961
- 0001033218
- 0001230940
- 0000618126
- 0000674644
- 0000710704
- 0000754296
- 0000787958
- 0000813050
- 0000842178
- 0000913984
- 0001058124
- 0001247962
- 0000621163
- 0000675505
- 0000712560
- 0000756186
- 0000789257
- 0000813513
- 0000844340
- 0000920455
- 0001066337
- 0001253080
- 0000623947
- 0000679068
- 0000713835
- 0000757391
- 0000790109
- 0000815931
- 0000845669
- 0000924209
- 0001079438
- 0001254942
- 0000625488
- 0000680521
- 0000716921
- 0000758216
- 0000792155
- 0000819855
- 0000846562
- 0000930032
- 0001082058
- 0000629193
- 0000681987
- 0000720026
- 0000763463
- 0000792754
- 0000820680
- 0000848744
- 0000936882
- 0001087141
- 0000632783
- 0000683415
- 0000722711
- 0000770118
- 0000795825
- 0000822396
- 0000850633
- 0000940957
- 0001109728
- 0000634781
- 0000686675
- 0000726265
- 0000771337
- 0000797234
- 0000823128
- 0000852266
- 0000948040
- 0001114237
- 0000642067
- 0000688508
- 0000727477
- 0000773131
- 0000799971
- 0000824755
- 0000853523
- 0000950415
- 0001143575
- 0000645260
- 0000689009
- 0000732859
- 0000775810
- 0000800826
- 0000826376
- 0000854865
- 0000973852
- 0001158478
- 0000647568
- 0000693830
- 0000734824
- 0000777688
- 0000803213
- 0000828382
- 0000856461
- 0000977519
- 0001171997
- 0000650689
- 0000695724
- 0000739439
- 0000778675
- 0000803622
- 0000829857
- 0000878369
- 0000988075
- 0001178624
- 0000654974
- 0000696014
- 0000741833
- 0000779991
- 0000806427
- 0000831660
- 0000882363
- 0001000210
- 0001181619
- Lot code
- 5921-018-235
- CONNECT-018-235
- 5921-024-235
- CONNECT-024-235
Recall details
- Company began the recall
- Sold in
U.S.: Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, 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 York, OHJ, Oklahoma, Oregon, Pennsylvania South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, and Washington. O.U.S.: N/A
- Company
- Stryker Sustainability SolutionsTempe, Arizona
- 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
- 98504
- Recall number
- Z-1804-2026
- Quantity recalled
- 56,740 cuffs
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.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
