# FDA recall Z-2166-2026

> **Stryker Corporation** · Class II · device recall initiated 2026-04-09.

## Product

Thermedx FluidSmart Urology Tube Set REF LL0006  UDI-DI code: 00860936000365    The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

## Reason for recall

Due to nonconforming products being inadvertently distributed.

## Distribution

U.S. Nationwide distribution in the state of GA.

## Key facts

- **Recall number:** Z-2166-2026
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-09
- **Report date:** 2026-05-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2026

## Citation

> MORVS. FDA recall Z-2166-2026. Retrieved 2026-10-19 from https://api.morvs.ai/recall/Z-2166-2026. Source: US FDA. Licensed CC0.

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