{"url_path":"/fda/device/recalls/Z-2166-2026","section_key":"summary","section_title":"DEVICE Recall: 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, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, ur…","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-04-09","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Stryker Corporation"},"word_count":108,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2166-2026\n\n**Recalling firm:** Stryker Corporation\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-04-09\n**Report date:** 2026-05-20\n\n## Product\nThermedx 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.\n\n## Reason\nDue to nonconforming products being inadvertently distributed.\n\n## Affected lots\nCatalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601\n\n## Distribution\nU.S. Nationwide distribution in the state of GA."}