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.

Class II

Recalling firm: Stryker Corporation
Reason for recall: Due to nonconforming products being inadvertently distributed.
Affected products (lot / model / serial): Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Units affected: 10 tube sets
Distribution pattern: U.S. Nationwide distribution in the state of GA.
Firm location: San Jose, CA, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Letter
Product type: Devices
Status: Ongoing
Recall number: Z-2166-2026
Recall initiated: April 9, 2026
FDA classification date: May 12, 2026
FDA report date: May 20, 2026
FDA event ID: 98696
Last updated on HTM Vibe: July 24, 2026