Thermedx FluidSmart Urology Tube Set
Due to nonconforming products being inadvertently distributed.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
Stryker Corporation of San Jose, California, recalled 10 Thermedx FluidSmart Urology Tube Set REF LL0006 units, identified by UDI-DI code 00860936000365, because nonconforming products were inadvertently distributed.
The tube sets are intended for use with the FluidSmart Fluid Management System for irrigation and fluid warming in laparoscopic procedures, and for distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
The recall began on April 9, 2026, and was added to the FDA's Enforcement Report on May 12, 2026, with distribution in the state of Georgia.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI and lot code listed under your product.
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets
- UDI-DI
- 00860936000365
- Lot
- B000576601
Details
- Company began the recall
- Sold in
U.S. Nationwide distribution in the state of Georgia.
- Event ID
- 98696
- Recall No.
- Z-2166-2026
- Company
- Stryker CorporationSan Jose, California
- Hazard
- Device defect
- Quantity recalled
- 10 tube sets
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Letter
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
