Stryker Sustainability Solution Color Cuff 24" — Class II medical device recall Z-1804-2026
Ongoing recall by Stryker Sustainability Solutions, reported 2026-04-15, distributed in AL, AR, AZ, CA, CO, CT, DC, DE…. Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the c
| Recall number | Z-1804-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Sustainability Solutions, Tempe, AZ, United States |
| Recall initiated | 2026-03-12 |
| Classified | 2026-04-09 |
| Reported by FDA | 2026-04-15 |
| Distributed | 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 |
| Quantity | 56,740 cuffs |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 50885825016024, 50885825016062, 50885825016116 |
| Lot numbers | 0000608407, 0000609378, 0000609899, 0000610592, 0000610593, 0000610595, 0000611745, 0000613383, 0000613711, 0000614822, 0000618126, 0000618222, 0000621163, 0000623945, 0000623947, 0000625488, 0000626120, 0000628325, 0000629193, 0000632783, 0000633577, 0000634780, 0000634781, 0000636292, 0000638716, 0000642067, 0000643088, 0000645259, 0000645260, 0000645991, 0000647073, 0000647074, 0000647568, 0000649426, 0000650589, 0000650590, 0000650689, 0000650994, 0000652336, 0000654974 and 363 more |
| Model numbers | 5921-018-135, 5921-018-235, 5921-024-235 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1804-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.