Diasol recalls
Diasol appears in 8 official U.S. recall notices indexed by RecallRadar, most recently on 2025-12-31.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 8 |
|---|---|
| Published | 2020-06-24 to 2025-12-31 |
| By agency | FDA Device (8) |
| By classification | Class II (8) |
| By status | ongoing (7), terminated (1) |
| Distribution named in notices | CA, US |
Recalls
- Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured - Brand Name: Diasol Product Name: 100125-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured - Brand Name: Diasol Product Name: 100425-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured - Brand Name: Diasol Product Name: 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured - Brand Name: Diasol Product Name: 100220-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured - Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
FDA Device · Class II · 2025-12-31 · Diasol
Reason: Safety and efficacy of dialysis acid concentrate cannot be assured - Diasol Acid Concentrate REF G100325-10Dex 100
FDA Device · Class II · 2024-10-30 · Diasol
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. - DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
FDA Device · Class II · 2020-06-24 · Diasol
Reason: Incorrect labeling of dialysate concentration for hemodialysis.