Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be…

Recall date

April 9, 2026

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2166-2026

FDA classification

Class II

Brand / firm

Stryker Corporation

Sold / distributed

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

Why it was recalled

Due to nonconforming products being inadvertently distributed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.