Stryker Corporation Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code recall: Due to nonconforming products being inadvertently distributed
Due to nonconforming products being inadvertently distributed.
The hazard: Device safety concern
A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
What the notice says: Due to nonconforming products being inadvertently distributed.
Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.
Recall details
- Recall number
- Z-2166-2026
- Published
- May 20, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Stryker Corporation
- Product type
- Medical devices
- Units affected
- 10 tube sets
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
- UPC codes
- 00860936000365
Products covered by this recall
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.
Check your product
The notice names 1 code you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 00860936000365
Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Device
Stryker Corporation — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.
- Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
- If you are a facility, quarantine affected stock and log the correction.
- Report device problems to the FDA through MedWatch.
- If the device is implanted or you depend on it daily, speak to your clinician before changing how you use it.
Claiming on a recalled device
Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.
- Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
- Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
- If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
- Log the date, the name and the reference number of every call. Device recalls can run for months.
Company contact: Stryker Corporation — 5900 Optical Ct, San Jose, CA, 95138-1400
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Stryker Corporation medical devices recalled?
Due to nonconforming products being inadvertently distributed. Due to nonconforming products being inadvertently distributed.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 00860936000365. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
Can I get my money back?
Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
Where was the recalled product sold?
It was distributed nationwide.
Related recalls
-
Class II · 2 months ago
Stryker Ahto Dual Spike Tube SET Packaging recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
-
Class II · 2 months ago
Stryker Ahto Tube SET Packaging recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
-
Class II · 2 months ago
Stryker PKG., Single Spike Tube SET recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
-
Class II · 2 months ago
Stryker Ahto Tube SET With TIP Packaging recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
-
Class II · 2 months ago
Stryker PKG., Strykeflow Suction/Irrigator PS recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
-
Class II · 3 months ago
Stryker Hoffmann II Connecting Rod Micro 3 x 40mm recall: Potential cracking of the Hoffmann II Carbon Connecting Rods following
Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.