Phoenix, AZ, United States
Diasol, Inc recalls
3 recalls recorded since 2018, most recently on 5 November 2025. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 November 2025
- Reason
- Safety and efficacy of dialysis acid concentrate cannot be assured
- Distribution
- US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0992-2026, Z-0987-2026, Z-0989-2026, Z-0991-2026, Z-0988-2026, Z-0990-2026
- Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
- Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Ongoing Class II Medical devices
- Recall started
- 27 July 2022
- Reason
- Due to labeling issue. The box label is different that the gallon label in that gallon label shows a lower Calcium concentration than the box label.
- Distribution
- U.S. Nationwide distribution in the state of AZ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0207-2025
- Diasol Acid Concentrate REF G100325-10Dex 100
Terminated Class II Medical devices
- Recall started
- 30 April 2020
- Terminated
- 28 May 2024
- Reason
- Incorrect labeling of dialysate concentration for hemodialysis.
- Distribution
- U.S.: CA O.U.S.:None
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2402-2020
- DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.