Brand Name: Diasol Product Name: 100425-10-DEX100 — Class II medical device recall Z-0992-2026
Ongoing recall by Diasol, Inc, reported 2025-12-31, distributed nationwide. Safety and efficacy of dialysis acid concentrate cannot be assured
| Recall number | Z-0992-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Diasol, Inc, Phoenix, AZ, United States |
| Recall initiated | 2025-11-05 |
| Classified | 2025-12-23 |
| Reported by FDA | 2025-12-31 |
| Distributed | Nationwide (US) |
| Quantity | 2,200 gallons |
| Lot numbers | PHV08042 |
Product
Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Reason for recall
Safety and efficacy of dialysis acid concentrate cannot be assured
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-0992-2026. 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.