Official recall notice
FDA DeviceClass IINotable
Thermedx FluidSmart Urology Tube Set Recall (May 2026) – Stryker
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.
- Recall date
- 2026-05-20
- Brand
- Stryker Corporation
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Due to nonconforming products being inadvertently distributed.
Product description
Due to nonconforming products being inadvertently distributed.