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Diasol Recalls Dialysis Concentrate Over Safety Concerns

Diasol recalled 4,400 gallons of its 100230-10-DEX100 dialysis acid concentrate on November 5, 2025. The company cannot assure the safety and efficacy of this product. Healthcare providers and patients must stop using the concentrate immediately.

Official notice
DiasolHealth & Personal CareMedical DevicesUDI: None/Lot Code: PHV07222PHV09082

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
Multiple Retailers
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
Dialysis Acid Concentrate
Model numbers
UDI: None/Lot Code: PHV07222, PHV09082
Sold at
Multiple Retailers
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 100230-10-DEX100 is a liquid concentrate used in bicarbonate dialysis. Patients undergoing dialysis use this product to manage their treatment effectively.

Why This Is Dangerous

The recall stems from concerns that the safety and efficacy of the dialysis acid concentrate cannot be assured, which could lead to serious health risks for patients.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients reliant on this dialysis concentrate face significant health risks, creating an urgent need for replacements.

Practical Guidance

How to identify if yours is affected

  1. Check the lot code on the product packaging to see if it matches PHV07222 or PHV09082.
  2. Review any recall notifications from your healthcare provider or Diasol, Inc.
  3. Contact your healthcare provider for advice on alternative treatments.

Where to find product info

Lot codes can typically be found on the product label or packaging.

What timeline to expect

Expect a refund processing timeline of 4-6 weeks after submitting your request.

If the manufacturer is unresponsive

  • Reach out again via email or phone to Diasol, Inc.
  • Document all correspondence and attempts to contact the company.

How to prevent similar issues

  • Look for FDA-approved products when purchasing medical devices.
  • Always check for safety recalls before using medical supplies.
  • Consult with healthcare providers about alternative products.

Documentation advice

Keep copies of all communications regarding the recall and any medical advice received.

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Product Details

The recall affects 4,400 gallons of Diasol's 100230-10-DEX100 Dialysis Acid Concentrate. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.

Key Facts

  • Recall date: November 5, 2025
  • Quantity recalled: 4,400 gallons
  • States affected: MO, CA, AZ, TX, IL, MA
  • Hazard classification: Class II
  • Immediate action required

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: PHV07222
PHV09082
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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