# FDA recall Z-1344-2023

> **Stryker Corporation** · Class II · device recall initiated 2023-03-01.

## Product

Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK  Catalog number: 5921-218-235NS    Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities

## Reason for recall

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1344-2023
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-03-01
- **Report date:** 2023-04-12

- **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-1344-2023

## Citation

> AI Analytics. FDA recall Z-1344-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1344-2023. Source: US FDA. Licensed CC0.

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