FDA recall record

NIPRO Technical Services Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011 recall — FDA Z-1185-2026

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

Class IIclassification
Z-1185-2026official record ID
Feb 4, 2026report date

Recall record at a glance

Official recordZ-1185-2026
CategoryMedical Device Recalls
ClassificationClass II
FDA record statusOngoing
Recalling firmNIPRO Technical Services, Inc.
Report dateFeb 4, 2026
Recall initiation dateDec 12, 2025
Quantity499 units
LocationMesa, AZ, United States

Official 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

Why the product was recalled

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.

Distribution information

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.

How to read the classification

FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.

Additional record details

Recall type: Voluntary: Firm initiated. Initial notification: Letter.

What to do next

If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.

About this record

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