FDA Device recall Z-1804-2026
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solu…
- FDA Device
- Class II
- ongoing
- Published 2026-04-15
On 2026-04-15 the FDA classified a Class II recall of Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solu… by Stryker Sustainability Solutions, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1804-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-12 |
| Published | 2026-04-15 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Stryker Sustainability Solutions |
| Distribution | 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, OK, OR, PA, SC, SD, TN, TX, VA, VT, WA |
Product
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.
Reason
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.
Identifiers
| code_info | 5921-018-135 COLOR CUFF SINGLE PORT, SINGLE BLADDER 18" (RED), QUICK CONNECT-018-135 COLOR UDI-DI code: 50885825016024…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 0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1804-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.