FDA Medical devices recall ·
Thermedx FluidSmart Urology Tube Set recall
- Recall number
- Z-2166-2026
- Date
- (initiated April 9, 2026)
- Company / brand
- Stryker Corporation
5900 Optical Ct, San Jose, CA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 10 tube sets
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines.
Why was it recalled?
Due to nonconforming products being inadvertently distributed.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601
Distribution
U.S. Nationwide distribution in the state of GA.
States: Georgia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2166-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.