Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The... recall (Stryker Corporation)
Medical deviceClass IIOngoing
Summary: Stryker Corporation is recalling 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/defic. Reason: Due to nonconforming products being inadvertently distributed.
What is being recalled
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.
Why
Due to nonconforming products being inadvertently distributed.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
U.S. Nationwide distribution in the state of GA. (states named: Georgia)
How to tell if yours is affected
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2166-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 9, 2026 |
| Reported | May 20, 2026 |
| Company | Stryker Corporation |
| Company location | San Jose, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 10 tube sets |
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