Recall Z-2166-2026— Stryker Corporation
Class II · Ongoing
Class II FDA medical device recall by Stryker Corporation, initiated 2026-04-09. It names one FDA 510(k) clearance: K172048. 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..
- Recalling firm
- Stryker Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-04-09
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.