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.
- Brand
- Stryker Corporation
- 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.
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