Stryker Sustainability Solution Color Cuff 24” (Yellow) Quick Connect Dual Port Single Bladder
Medical device recall Z-1804-2026. Published in FDA’s Enforcement Report on Apr 15, 2026.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 15, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- 41 states named in where it went
- 56,740 cuffs how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
56,740 cuffs, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,997 characters
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…
FDA’s list runs to 4,813 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
U.S.: 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, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A
The states and territories these words name
41 states and territories.
Every one of them
- 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
The words say it went outside the United States too.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Is it still going on?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 12, 2026.
- FDA classified it on Apr 9, 2026.
- FDA’s Enforcement Report published it on Apr 15, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Sustainability Solutions, of Tempe, AZ.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 4,813 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
-
U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.