CLASS II ONGOING Device recall · Reported 31 Dec 2025 · FDA Enforcement Report

100225-10-DEX100, Liquid Concentrate recalled by Diasol

Diasol is recalling 100225-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 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

Lot, batch or date codesUDI: None; Lot Code: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131

Quantity recalled186,000 containers

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-0987-2026
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: E-Mail
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: 100225-10-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 Arizona California Illinois Massachusetts Missouri Texas

Questions about this recall

Why was it recalled?

Safety and efficacy of dialysis acid concentrate cannot be assured

Which lots are affected?

UDI: None; Lot Code: PHV07181 PHV07211 PHV07231 PHV07251 PHV07281 PHV07282 PHV07301 PHV07302 PHV07311 PHV08011 PHV08041 PHV08051 PHV08061 PHV08071 PHV08111 PHV08121 PHV08131 PHV08132 PHV08141 PHV08151 PHV08181 PHV08251 PHV08252 PHV09021 PHV09041 PHV09081 PHV09091 PHV09121 PHV09151 PHV09161 PHV09181 PHV09191 PHV09221 PHV09231 PHV09291 PHV10031 PHV10061 PHV10081 PHV10091 PHV10131

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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

5 other products · FDA event 97989

This product is part of a recall event; the main page for the event is 100425-10-DEX100, Liquid Concentrate recalled by Diasol.

Reported	Class	Recall	Company	Reason	Where
31 Dec 2025	CLASS II	100425-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025	CLASS II	100220-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025	CLASS II	100325-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025	CLASS II	100125-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025	CLASS II	100230-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide

More recalls from Diasol

All 8

Reported	Class	Recall	Company	Reason	Where
31 Dec 2025Device	CLASS II	100230-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025Device	CLASS II	100125-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025Device	CLASS II	100325-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025Device	CLASS II	100220-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide
31 Dec 2025Device	CLASS II	100425-10-DEX100, Liquid Concentrate recalled by Diasol	Diasol	Other	Nationwide

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All 13,884

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