# FDA recall Z-0992-2026

> **Diasol, Inc** · Class II · device recall initiated 2025-11-05.

## 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

## Distribution

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

## Key facts

- **Recall number:** Z-0992-2026
- **Recalling firm:** Diasol, Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-11-05
- **Report date:** 2025-12-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Phoenix, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0992-2026

## Citation

> AI Analytics. FDA recall Z-0992-2026. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0992-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*
