Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2166-2026·Announced 2026-05-20

Thermedx FluidSmart Urology Tube Set recalled for nonconforming products

Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall. The source text states nonconforming products were distributed but provides no information about reported illnesses, injuries, or specific performance failures. Without evidence of harm or a high-risk hazard, this falls into the Moderate category per the rubric.

Plain-English summary

Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set, Catalog Number LL0006 (UDI-DI code: 00860936000365), Lot Number B000576601. The FluidSmart Tube Sets are components of the FluidSmart Fluid Management System and are intended for irrigation and fluid warming in laparoscopic procedures, as well as distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.

The recall was initiated because nonconforming products were inadvertently distributed. Approximately 10 tube sets were affected and distributed nationwide in the state of Georgia.

Patients or healthcare facilities that have received this product should contact Stryker Corporation for instructions on how to proceed. The FDA has classified this recall as Class II.

The recalled product

Product: 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…
Manufacturer: Stryker Corporation
Category: Medical Device — Surgical / Laparoscopic Equipment
Hazard: nonconforming-device
Affected units: 10

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Stryker Corporation

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