Diasol, Inc: Medical Device Recall in 2025 - (Recall #: Z-0991-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Brand Name: Diasol Product Name: 100325-10-DEX100, Liquid Concentrate for Bicarbonate Dialysis Non Pyrogenic, 2K, 3.0CA, 1.0MG, 208.2 liters

Product Classification:

Class II

Date Initiated: November 5, 2025

Date Posted: December 31, 2025

Recall Number: Z-0991-2026

Event ID: 97989

Reason for Recall:

Safety and efficacy of dialysis acid concentrate cannot be assured

Status: Ongoing

Product Quantity: 74,400 gallons

Code Information:

UDI: None/Lot Code: PHV07221 PHV07241 PHV07291 PHV08182 PHV08201 PHV08221 PHV08271 PHV09031 PHV09051 PHV09101 PHV09111 PHV09152 PHV09171 PHV09241 PHV09251 PHV09261 PHV10071

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated