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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Stryker Sustainability Solution Color Cuffs Recalled for Pressure Loss

Agency Publication Date: April 9, 2026
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Summary

Stryker Sustainability Solutions is recalling approximately 56,740 tourniquet cuffs because they can detach at the welding connection between the cuff and the internal bladder. This defect causes the cuff to lose its ability to maintain pressure during medical procedures. The recall affects several models of the Color Cuff including 18-inch (Red) and 24-inch (Yellow) versions. No injuries have been reported, but a loss of pressure during surgery can lead to complications.

Risk

The cuff may suddenly detach from its inflation bladder, causing an immediate loss of pressure. This failure can result in unexpected bleeding or a compromised surgical field, potentially delaying medical procedures or causing injury to the patient.

What You Should Do

  1. Stop using the recalled tourniquet cuffs immediately. This applies to Stryker Sustainability Solution Color Cuff models REF 5921-024-235 (Yellow, 24-inch), REF 5921-018-135 (Red, 18-inch), and REF 5921-018-235 (Red, 18-inch).
  2. Check the model and lot numbers on the device packaging to determine if your inventory is affected. See the Affected Products section below for the full list of affected codes.
  3. Contact Stryker Sustainability Solutions or your distributor to arrange for the return, replacement, or correction of any affected units in your facility.
  4. Call the FDA Consumer Complaint hotline at 1-888-463-6332 (1-888-INFO-FDA) for additional questions regarding this medical device recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder
Variants: Red, 18-inch, Single Port, Quick Connect
Model / REF:
5921-018-135
Serial Numbers (143):
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
UDI:
50885825016024

COLOR CUFF SINGLE PORT, SINGLE BLADDER 18" (RED)

Product: Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder
Variants: Red, 18-inch, Dual Port, Quick Connect
Model / REF:
5921-018-235
Serial Numbers (107):
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
UDI:
50885825016062

COLOR CUFF DUAL PORT, SINGLE BLADDER 18" (RED)

Product: Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder
Variants: Yellow, 24-inch, Dual Port, Quick Connect
Model / REF:
5921-024-235
Serial Numbers (151):
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
UDI:
50885825016116

COLOR CUFF DUAL PORT, SINGLE BLADDER 24" (YELLOW)

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98504
Status: Active
Manufacturer: Stryker Sustainability Solutions
Sold By: Stryker Sustainability Solutions; Hospital Distributors
Manufactured In: United States
Units Affected: 56,740
Distributed To: 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, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Virginia, Vermont, Washington

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.