Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2166-2026 — 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

U.S. FDA — Device Enforcement · United States · 2026-04-09 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2166-2026
Date of alert
2026-04-09
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
00860936000365
Reported risk: Due to nonconforming products being inadvertently distributed.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.