FDA Device recall Z-2166-2026
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the Fluid…
- FDA Device
- Class II
- ongoing
- Published 2026-05-20
On 2026-05-20 the FDA classified a Class II recall of Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the Fluid… by Stryker, citing due to nonconforming products being inadvertently distributed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2166-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-09 |
| Published | 2026-05-20 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Stryker |
| Distribution | US |
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
Due to nonconforming products being inadvertently distributed.
Identifiers
| code_info | Catalog Number: LL0006 UDI-DI code: 00860936000365 Lot Number: B000576601 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2166-2026%22
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