UnratedMedical device recall · FDA · Published April 9, 2026
Stryker FluidSmart Urology Tube Set Recall: Nonconforming Products Distributed
Stryker recalls FluidSmart Urology Tube Set REF LL0006 with UDI-DI code 00860936000365 due to nonconforming products being inadvertently distributed. Affected units may have safety risks.
“Stryker FluidSmart Urology Tube Set Recall: Nonconforming Products Distributed.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49530-stryker-fluidsmart-urology-tube-set-recall-nonconforming-products-distributed. Based on FDA recall #Z-2166-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2026%22&limit=1).
The FDA announced on April 9, 2026, that Stryker Corporation is recalling Thermedx FluidSmart Urology Tube Sets due to nonconforming products being inadvertently distributed. The agency issued recall number Z-2166-2026 for the Class II voluntary recall.
How to tell if you have it
Brand: Stryker
Product: Thermedx FluidSmart Urology Tube Set
Catalog Number (REF): LL0006
UDI-DI code: 00860936000365
Lot Number: B000576601
The hazard
The recall is due to nonconforming products being inadvertently distributed. The FluidSmart Tube Sets are intended for use with the FluidSmart Fluid Management System for irrigation, fluid warming, and measurements in laparoscopic and endoscopic procedures.
Context
GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Recent Stryker recalls include the June 8, 2026 Ahto Dual Spike Tube Set leak issue and the May 6, 2026 Neptune Smart Docking Station electrical shock risk. Other recent recalls of similar products include the Medline TRACH TUBE KIT labeling discrepancy (July 10, 2026), the ReCor Paradise Ultrasound Renal Denervation System nonconforming product hazard (January 29, 2026), and the Bard PowerPICC SOLO HF Catheter lidocaine ampoules deficiency (May 21, 2026).
How to tell if you have this one
Check for the product name 'FluidSmart Urology Tube Set', reference code LL0006, and UDI-DI code 00860936000365. These items were distributed with Lot Number B000576601.
Brand
Stryker
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Verify the UDI-DI code 00860936000365 and reference number LL0006 on the tube set.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “U.S. Nationwide distribution in the state of GA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 41 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2166-2026 (April 9, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2166-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.