HIGH

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...

Due to nonconforming products being inadvertently distributed.

Quick Facts at a Glance

Recall Date
April 9, 2026
Hazard Level
HIGH
Brand
Stryker
Geographic Scope
1 states

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Stryker
Model numbers
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Where affected
ALL

Hazard Information

Due to nonconforming products being inadvertently distributed.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Stryker Corporation or your healthcare provider for instructions. Notification method: Letter

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Full Description

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.. Reason: Due to nonconforming products being inadvertently distributed.. Classification: Class II. Quantity: 10 tube sets. Distribution: U.S. Nationwide distribution in the state of GA.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

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Product Classification

Product Details

Brand
Model Numbers
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Affected States
ALL
Report Date
May 20, 2026
Recall Status
ACTIVE

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