Medical Device Recall: 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 irri
Stryker Corporation · April 9, 2026
Reason for Recall
Due to nonconforming products being inadvertently distributed.
Product Description
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.
Distribution
U.S. Nationwide distribution in the state of GA.
States Affected
NATIONWIDE
Quantity Affected
10 tube sets
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2166-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.