Class II — Diasol, Inc
| Recalling firm | DIASOL, INC. |
|---|---|
| Registered facility | DIASOL INC (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Safety and efficacy of dialysis acid concentrate cannot be assured |
| Product | Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters |
| Quantity | 7,200 gallons |
| Distribution | US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA. |
| Initiated | 2025-11-05 |
| Classified | 2025-12-23 |
| Recall number | Z-0988-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Diasol, Inc (Z-0988-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97989/
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