FDAFDA · Food and drugs·Recall number Z-2166-2026
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.
Published May 20, 2026 · Recall initiated: April 9, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Due to nonconforming products being inadvertently distributed.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- U.S. Nationwide distribution in the state of GA.
- Lot
- Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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