Color Cuff Disposable Tourniquet Cuff — Class II medical device recall Z-0592-2020
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2019-12-11, distributed nationwide. There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
| Recall number | Z-0592-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2019-11-06 |
| Classified | 2019-12-02 |
| Reported by FDA | 2019-12-11 |
| Terminated | 2021-11-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, AU, CA, NL |
| Quantity | 16,380 total |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 37613154599258 |
| Lot numbers | 60180348, 60180373 |
Product
Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 1PRT(Single Port) Quick Connect Connector, Product Number 5921-018-135 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.
Reason for recall
There is a potential for the cuff to leak air leading to a loss of vascular occlusion.
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-0592-2020. 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.