Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Color Cuff Disposable Tourniquet Cuff Recalled by Stryker Instruments Div. of Stryker Corporation Due to There is a potential for the cuff to...

Date: November 6, 2019
Company: Stryker Instruments Div. of Stryker Corporation
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.

Affected Products

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.

Quantity: 16,380 total

Why Was This Recalled?

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Stryker Instruments Div. of Stryker Corporation

Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report