Quick Facts at a Glance
- Recall Date
- March 12, 2026
- Hazard Level
- HIGH
- Brand
- Stryker Sustainability Solutions
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- Nationwide (50 states)
- At-Risk Groups
- GENERAL, PREGNANT, PETS
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Stryker Sustainability Solutions
- Product type
- Tourniquet/Cuff System
- Model numbers
- 5921-018-135 COLOR CUFF SINGLE PORT, SINGLE BLADDER 18" (RED), QUICK CONNECT-018-135 COLOR UDI-DI code: 50885825016024 Serial/Lot Numbers: 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 5921-018-235 COLOR CUFF DUAL PORT, QUICK CONNECT-018-235 UDI-DI code: 50885825016062 Serial/Lot Numbers: 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 5921-024-235 COLOR CUFF DUAL PORT, SINGLE BLADDER 24" (YELLOW), QUICK CONNECT-024-235 UDI-DI code: 50885825016116 Serial/Lot Numbers 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
- Colors
- YELLOW, RED
- Sizes
- 18", 24"
- Sold at
- Multiple Retailers
- Where affected
- Nationwide
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 12, 2026
Reported by FDA DEVICE
April 15, 2026
RecallRadar source check
April 22, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Sustainability Solutions or your healthcare provider for instructions. Notification method: Letter
About This Product
Color Cuff systems are used to apply tourniquet pressure in surgical procedures. They are critical for maintaining proper blood flow control.
Why This Is Dangerous
Detachment at the welding connection can cause the cuff to lose pressure, compromising tourniquet function.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Immediate action is required to prevent potential lapses in tourniquet pressure during procedures.
Practical Guidance
How to identify if yours is affected
- Verify UDI codes and serial numbers listed in the recall documentation.
- Look for color and size markers: Yellow 24" cuff, Red 18" cuff.
Where to find product info
Refer to the recall notice and FDA enforcement page for official identifiers.
What timeline to expect
Refunds/Replacements timelines vary by manufacturer; expect several weeks.
If the manufacturer is unresponsive
- Document attempts to contact the manufacturer
- Escalate to the hospital's risk management or patient safety office
- File a complaint with the FDA if necessary
How to prevent similar issues
- Verify cuff compatibility before use
- Maintain updated recall notifications from hospital procurement
- Educate surgical teams on identifying recalled components
Documentation advice
Keep model numbers, serials/UDIs, and all correspondence as part of your records
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Product Details
Model numbers: 5921-024-235 (24" Yellow), 5921-018-135 (18" Red Single Port), 5921-018-235 (18" Red Dual Port), 5921-024-235 (24" Yellow Dual Port). Sold and distributed in the U.S. across AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA. Total quantity recalled: 56,740 cuffs. Recall date: 2026-03-12. Status: ACTIVE.
Reported Incidents
No specific incidents or injuries are listed in the provided data.
Key Facts
- 3 models in 18" and 24" configurations
- Distributed across 50+ U.S. states
- Detachment at welding connection risk
- High hazard level
- Recall status ACTIVE
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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