Recall Z-1185-2026— NIPRO Technical Services, Inc.

Name: FDA recall Z-1185-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-12

Class II · Ongoing

Class II FDA medical device recall by NIPRO Technical Services, Inc., initiated 2025-12-12. It names one FDA 510(k) clearance: K041636. Product: Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters. Reason: due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate..

Recalling firm: NIPRO Technical Services, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-12
Firm location: Mesa, AZ, United States

510(k) clearances named in this recall

1 on FDA's record

K041636 — H&S-CONDUCTIVITY STANDARD SOLUTIONH & S Technical Services·cleared 2004-07-02

K-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

Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters

Reason for recall

due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.

Data sourced from openFDA. This site is unofficial and independent of the FDA.