CLASS II ONGOING Device recall · Reported 20 May 2026 · FDA Enforcement Report

Thermedx FluidSmart Urology Tube Set recalled by Stryker

Stryker is recalling Thermedx FluidSmart Urology Tube Set, distributed nationwide in the US. The recall was initiated on 9 Apr 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

Quantity recalled10 tube sets

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2166-2026
FDA event ID: 98696
Recalling firm: Stryker, San Jose, CA
Classification: Class II
Status: Ongoing
Recall initiated: 9 Apr 2026
FDA classified: 12 May 2026
Reported: 20 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

9 Apr 2026	Recall initiated by company
12 May 2026	Classified by FDA	+33 days
20 May 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Due to nonconforming products being inadvertently distributed.

Product as listed by the FDA

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.

Where it was distributed

U.S. Nationwide distribution in the state of GA.

Nationwide Georgia

Questions about this recall

Why was it recalled?

Due to nonconforming products being inadvertently distributed.

Which lots are affected?

Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601

Where was it sold?

U.S. Nationwide distribution in the state of GA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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