Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code:… — Class II medical device recall Z-2166-2026
Ongoing recall by Stryker Corporation, reported 2026-05-20, distributed nationwide. Due to nonconforming products being inadvertently distributed.
| Recall number | Z-2166-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2026-04-09 |
| Classified | 2026-05-12 |
| Reported by FDA | 2026-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 10 tubes |
| UPC / GTIN / UDI-DI | 00860936000365 |
| Lot numbers | B000576601 |
| Model numbers | LL0006 |
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.
Reason for recall
Due to nonconforming products being inadvertently distributed.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2166-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.