HIGH

Diasol Recalls Dialysis Liquid Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its dialysis liquid concentrate on November 5, 2025. The recall follows concerns that the safety and efficacy of the product cannot be assured. Healthcare providers and patients should stop using the product immediately.

Quick Facts at a Glance

Recall Date
November 5, 2025
Hazard Level
HIGH
Brand
Diasol
Category
Health & Personal Care
Sold At
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Safety and efficacy of dialysis acid concentrate cannot be assured

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Diasol, Inc or your healthcare provider for instructions. Notification method: E-Mail

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Product Details

The recalled product is Diasol's Liquid Concentrate for Bicarbonate Dialysis, model numbers PHV08112 and PHV10082. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.

The Hazard

The recall was issued due to concerns over the safety and efficacy of the dialysis acid concentrate. This issue poses a significant risk to patients requiring dialysis treatment.

Reported Incidents

No specific incidents have been reported, but the potential risk to patients is classified as high due to the nature of the product.

What to Do

Patients and healthcare providers should stop using the product immediately. Follow the manufacturer's instructions for returning the product and contact Diasol, Inc. for further guidance.

Contact Information

For more information, contact Diasol, Inc. via email. Further details are available at the FDA's recall page.

Key Facts

  • Recall date: November 5, 2025
  • Quantity: 4,400 gallons
  • Class II recall status
  • Nationwide distribution in specific states

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Brand
Model Numbers
UDI: None/Lot Code: PHV08112
PHV10082
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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