Recalling firm
Stryker Corporation
Product type
Device
Status
Ongoing
Report date
2026-05-20
Distribution
U.S. Nationwide distribution in the state of GA.
Firm state
CA
Product quantity
10 tube sets
Initiated by
Voluntary: Firm initiated
Reason for recall
Due to nonconforming products being inadvertently distributed.
Product description
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.
Code / lot info
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.