Notice names this product. Stryker’s Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code is named in FDA Class II recall Z-2166-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Due to nonconforming products being inadvertently distributed. Identifying details: Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601. Units affected: 10 tube sets. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Due to nonconforming products being inadvertently distributed.
Company / brand: Stryker
Affected product: Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code
Official ID Z-2166-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.