Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity

FDA device recall Z-1185-2026 · posted 2026-01-27 · Open, Classified

Recall details

Recalling firm: NIPRO Technical Services, Inc.
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.
Action taken: On 12/12/2025, the firm mailed/emailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that specific lots of Conductivity Standard Solutions have been identified as not meeting specification requirements which potentially could result with inaccurate calibration leading to electrolyte imbalances consistent with hypo- or hypernatremia. Customer are instructed to" 1. Immediately stop using the affected products 2.Segregate and quarantine all affected units 3. Return the affected product for replacement or dispose of the product For questions associated with this recall or if further assistance is needed, contact Customer Service at 800-923-2486 or email sales@niprotechnical.com.
Root cause: Under Investigation by firm
Status: Open, Classified
Product code: FKH
Quantity affected: 499 units
Distribution: U.S. Nationwide distribution in the states of AL, AR, AZ, CA, DE, FL, GA. IL, IN, KS, MI, MO, NC, ND, NJ, NV, NY, OH, OK, OR, PA, SC, TN TX, UT, VA, and WA.
Date initiated: 2025-12-12
Date posted: 2026-01-27
Location: Mesa, AZ

Recalls and clearances share one API, with change alerts when new recalls post.

Record	Firm	Date
H&S-CONDUCTIVITY STANDARD SOLUTION (K041636)	H & S Technical Services	2004-07-02