FDA recall Z-2166-2026

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.

Distribution

U.S. Nationwide distribution in the state of GA.

Key facts

Status

Ongoing

Initiation date

2026-04-09

Report date

2026-05-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Jose, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2166-2026