Reported May 20, 2026 · Ongoing

Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be…

Stryker Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Stryker Corporation · 5900 Optical Ct · San Jose, CA · 95138-1400

Is this the product you have?

  • Thermedx FluidSmart
  • Urology Tube Set REF LL0006 UDI-DI code00860936000365 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
Lot codes and dates
  • Catalog NumberLL0006
  • UDI-DI code00860936000365
  • Lot NumberB000576601
Amount recalled
10 tube sets

Where it was sold

  • Nationwide
  • GA

Why it was recalled

Due to nonconforming products being inadvertently distributed.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:16 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.