What models are affected by the Stryker Color Cuff recall 2026?

Affected models include 5921-024-235 24" Yellow cuffs, 5921-018-135 18" Red Single Port, 5921-018-235 18" Red Dual Port, and 5921-024-235 Dual Port 24" Yellow cuffs. Check your serial/UDI codes in the recall notice.

What should I do if I own one of these cuffs?

Stop using the cuff immediately. Follow the manufacturer recall instructions and contact Stryker Sustainability Solutions for guidance or your healthcare provider.

Where can I find more recall details?

Visit the FDA enforcement page linked in the recall notice for official details.

Will I get a refund or replacement?

Manufacturer will provide recall instructions. Process timelines vary; follow the official guidance.

How can I identify the cuff in use?

Check model numbers and UDI codes listed in the recall documentation.

Is this recall part of a larger safety pattern?

This recall relates to detachment at the welding connection potentially compromising cuff pressure.

What if I cannot contact the manufacturer?

Follow the healthcare provider guidance and document your attempts to contact the manufacturer.

Are there risks if I continue to use an affected cuff?

The cuff may detach and fail to maintain proper pressure, potentially impacting patient care.

How long does the recall take to process refunds/replacements?

Timelines are determined by the manufacturer; expect several weeks in typical recalls.

Can I use a different cuff with the same system?

Only use recommended components from the manufacturer to ensure compatibility and safety.

What documentation should I keep?

Keep purchase records, serial/UDI codes, and all correspondence with manufacturer.

HIGHMarch 12, 2026

Stryker Sustainability Solutions Color Cuff Recall Expands to 56,740 Cuffs Over Detachment Risk (202

Stryker Sustainability Solutions recalled 56,740 color cuff tourniquet cuffs due to potential detachment from the bladder. The recall affects 18" and 24" cuffs across multiple U.S. states. Patients and healthcare providers should stop using these devices immediately and follow manufacturer instructions.

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

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

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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

Check model numbers 5921-024-235, 5921-018-135, 5921-018-235, 5921-024-235.
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

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

56,740 cuffs recalled
3 models in 18" and 24" configurations
Distributed across 50+ U.S. states
Detachment at welding connection risk
High hazard level
Recall status ACTIVE

View Original Recall on FDA - Medical Devices

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Safety Guide

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Safety Assessment

Risk LevelHIGH

Severity Score

8/ 10

Affected Groups

GENERALPREGNANTPETSINFANTSCHILDRENELDERLYPREGNANTPREGNANT

Injury Types

ELECTRICALLACERATIONPOISONINGBURNSUFFOCATIONOTHER

Product Classification

CategoryHealth & Personal Care › Medical Devices

Product TypeTourniquet/Cuff System

Product Details

Brand

Stryker Sustainability Solutions

Categories

Health & Personal Care Medical Devices

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)

+1 more

Affected States

Nationwide

Report Date

April 15, 2026

Source Agency

Incomplete seals on sterile product

Apr 10, 2026

Stryker Sustainability Solutions

Incomplete seals