FDA-Device2026-05-20Class IIPROCESSING DEFECT
Stryker Thermedx FluidSmart Urology Tube Set recalled for nonconforming products
What this means
Stryker Corporation recalled a limited lot of FluidSmart Urology Tube Sets (REF LL0006) used with fluid management systems in surgical procedures. Some units in this lot did not meet manufacturing standards. No injuries have been reported.
- Check if your facility received Lot B000576601 of Thermedx FluidSmart Urology Tube Set REF LL0006
- Do not use affected tube sets
- Contact Stryker or the FDA for return or replacement instructions
The agency's original wording
Hazard
Due to nonconforming products being inadvertently distributed.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the state of GA.
Affected count
10 tube sets
Manufactured in
5900 Optical Ct, San Jose, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2026Want us to check the next one for you?
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