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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.

Official notice
DiasolHealth & Personal CareMedical DevicesUDI: None/Lot Code: PHV08112PHV10082

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
November 5, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Diasol
Product type
Liquid Concentrate for Bicarbonate Dialysis
Model numbers
UDI: None/Lot Code: PHV08112, PHV10082
Sold at
Unknown
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    November 5, 2025

  2. Reported by FDA DEVICE

    December 31, 2025

  3. RecallRadar source check

    January 7, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

Diasol's Liquid Concentrate for Bicarbonate Dialysis is used in conjunction with dialysis machines to help manage patients' electrolyte levels. It is essential for patients undergoing dialysis treatment.

Why This Is Dangerous

The product's safety and efficacy cannot be assured, which poses a risk to patients who rely on it for critical treatment during dialysis.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall may cause inconvenience for healthcare providers and patients, necessitating immediate action to find safer alternatives.

Practical Guidance

How to identify if yours is affected

  1. Verify if your product model is PHV08112 or PHV10082.
  2. Check the lot codes on the packaging to confirm if affected.
  3. Contact your healthcare provider for additional verification.

Where to find product info

Look for model numbers and lot codes on the product packaging or labeling.

What timeline to expect

Expect a refund or replacement within 4-6 weeks after returning the product.

If the manufacturer is unresponsive

  • Document all communication attempts with Diasol.
  • Reach out to the FDA if Diasol does not respond.
  • Consider consulting legal advice if necessary.

How to prevent similar issues

  • Always check for recalls on medical devices and products before use.
  • Consult with healthcare providers about the safety of products used in medical treatments.
  • Look for certification marks indicating safety and efficacy.

Documentation advice

Keep copies of any receipts, emails, and correspondence regarding the recall for your records.

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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.

Key Facts

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

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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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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