Class II U.S. Food and Drug Administration

Stryker Sustainability Solution Color Cuff 24" Quick Connect Dual Port recall: Due to potential for tourniquet cuffs to detach from the bladder

Recall published 6 months ago

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.

The hazard: Device safety concern

The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-1804-2026
Published
April 15, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Stryker Sustainability Solutions
Product type
Medical devices
Units affected
56,740 cuffs
Distribution
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
Made in
United States
Lot / code info
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, SINGLE BLADDER 18" (RED), 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…
UPC codes
50885825016024, 50885825016062, 50885825016116

Products covered by this recall

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.

Check your product

The notice names 3 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 50885825016024
  • 50885825016062
  • 50885825016116

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Stryker Sustainability Solutions — The manufacturer or the FDA identified a problem with this device. The model, lot and catalogue numbers are what define the scope.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Report device problems to the FDA through MedWatch.
  3. If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
  4. Ask the supplier or clinic that provided it what the remedy is in your case.

Who pays for a device recall

The manufacturer funds the remedy. The practical question is usually which link in the chain executes it.

  • If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.
  • Ask for written confirmation that the remedy was applied to your serial number. That is what an insurer or a future clinician will want to see.
  • If you bought it yourself online or from a pharmacy, go to the manufacturer’s recall page rather than the retailer; device claims are handled centrally.
  • Where the remedy is a software update, there is nothing to claim, but do confirm the version changed afterwards.

Company contact: Stryker Sustainability Solutions — 1810 W Drake Dr, Tempe, AZ, 85283-4327

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Stryker Sustainability Solutions medical devices recalled?

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. 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.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 50885825016024, 50885825016062, 50885825016116. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

If a clinic fitted or supplied the device, start there — they hold the serial-number records the manufacturer needs.

Which states were affected?

The notice lists Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa and others.

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