Stryker SmartPump Tourniquet — Class II medical device recall Z-2277-2025
Ongoing recall by Stryker Corporation, reported 2025-08-13, distributed nationwide. Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be
| Recall number | Z-2277-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2025-07-02 |
| Classified | 2025-08-07 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, GB, HK, IN, MY, NL, NZ, SE, SG, TH |
| Quantity | 233.23 |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 07613154599257, 07613154599295, 07613154599370 |
Product
Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
Reason for recall
Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
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-2277-2025. 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.