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Home › FDA recalls › Thermedx FluidSmart Urology Tube Set REF LL0006
CLASS II · ModerateFDA

Stryker Corporation recalls Thermedx FluidSmart Urology Tube Set REF LL0006

📅 Apr 9, 2026 · 📍 Nationwide
Recalling company
Stryker Corporation
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.
Reason
Due to nonconforming products being inadvertently distributed.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Apr 9, 2026
Reported
May 20, 2026
Distribution
U.S. Nationwide distribution in the state of GA.
Status
Ongoing
Quantity
10 tube sets
Lot / codes
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Company location
San Jose, CA
Recall type
Voluntary: Firm initiated
Recall number
Z-2166-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2166-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.