Data Foundry

Medical device recalls 2026

Conductivity Standard Solution Catalog/Model Numbers: 10001 — Class II medical device recall Z-1185-2026

Ongoing recall by NIPRO Technical Services, Inc., reported 2026-02-04, distributed nationwide. due to a defect associated with the conductivity values of the solution used to calibrate meters and result in

Recall numberZ-1185-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmNIPRO Technical Services, Inc., Mesa, AZ, United States
Recall initiated2025-12-12
Classified2026-01-27
Reported by FDA2026-02-04
DistributedNationwide (US)
Quantity499 units
Model numbers10001, 10011, 10021, 10032, 10040, 10040C, 10041

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 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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1185-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.