# FDA recall Z-0593-2020

> **Stryker Instruments Div. of Stryker Corporation** · Class II · device recall initiated 2019-11-06.

## Product

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - 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.

## Distribution

Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.

## Key facts

- **Recall number:** Z-0593-2020
- **Recalling firm:** Stryker Instruments Div. of Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-06
- **Report date:** 2019-12-11
- **Termination date:** 2021-11-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0593-2020

## Citation

> AI Analytics. FDA recall Z-0593-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-0593-2020. Source: US FDA. Licensed CC0.

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