Diasol, Inc: Device Recall

Recall #Z-0992-2026 · 11/05/2025

Class II: Risk

Recall Details

Recall Number
Z-0992-2026
Classification
Class II
Product Type
Device
Recalling Firm
Diasol, Inc
Status
Ongoing
Date Initiated
11/05/2025
Location
Phoenix, AZ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2200 gallons

Reason for Recall

Safety and efficacy of dialysis acid concentrate cannot be assured

Product Description

Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Distribution Pattern

US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.