Recall
FDAHealthApril 9, 2026

Stryker Corporation — 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, whic

⚠️ Due to nonconforming products being inadvertently distributed.

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
April 9, 2026

U.S. Nationwide distribution in the state of GA.

What's affected?

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.
Lot code
B000576601

Additional details

Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 10 tube sets.

View original FDA notice →

Get Health recall alerts

Delivered to your inbox. Free. No account required.