CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report
100230-10-DEX100, Liquid Concentrate recalled by Diasol
Diasol is recalling Diasol 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, distributed nationwide in the US. The recall was initiated on 5 Nov 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0990-2026
- FDA event ID
- 97989
- Recalling firm
- Diasol, Phoenix, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 5 Nov 2025
- FDA classified
- 23 Dec 2025
- Reported
- 31 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 5 Nov 2025 | Recall initiated by company | |
| 23 Dec 2025 | Classified by FDA | +48 days |
| 31 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Safety and efficacy of dialysis acid concentrate cannot be assured
Product as listed by the FDA
Brand Name: Diasol Product Name: 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters
Where it was distributed
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
Nationwide ArizonaCaliforniaIllinoisMassachusettsMissouriTexas
Questions about this recall
Is 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 0CA, 0MG recalled?
Yes. Diasol recalled 100230-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 0CA, 0MG on 5 Nov 2025. The recall is Class II and its status is Ongoing. Recall number Z-0990-2026.
Why was it recalled?
Safety and efficacy of dialysis acid concentrate cannot be assured
Which lots are affected?
UDI: None/Lot Code: PHV07222,PHV09082
Where was it sold?
US Nationwide distribution in the states of MO, CA, AZ, TX, IL, MA.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Diasol
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|---|---|---|---|---|---|
| Device | CLASS II | 100125-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100325-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100220-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100225-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
| Device | CLASS II | 100425-10-DEX100, Liquid Concentrate recalled by Diasol | Diasol | Other | Nationwide |
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