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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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 Dialysis
- Model numbers
- UDI: None/Lot Code: PHV08042
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 5, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
January 7, 2026
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 100425-10-DEX100 is used as a liquid concentrate for bicarbonate dialysis, which is essential for patients undergoing dialysis treatment. Consumers purchase this product for its role in assisting with their medical needs during dialysis.
Why This Is Dangerous
The recall is based on the inability to assure the safety and efficacy of the dialysis acid concentrate, which is critical for patient health.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects patients who rely on this product for dialysis, requiring immediate action to avoid potential health risks.
Practical Guidance
How to identify if yours is affected
- Check the lot code on your product to determine if it is PHV08042.
- Contact your healthcare provider if you are unsure about your product.
- Review any communications from Diasol regarding this recall.
Where to find product info
The lot code can typically be found on the product label or packaging.
What timeline to expect
Expect a response from Diasol within a few weeks regarding the recall and any potential refunds or replacements.
If the manufacturer is unresponsive
- Reach out again via email or phone.
- Document your communications for reference.
- Consider contacting regulatory authorities if the issue persists.
How to prevent similar issues
- Look for products with clear safety certifications.
- Consult with healthcare providers about safer alternatives.
- Stay updated on recall notices in the healthcare sector.
Documentation advice
Keep records of your purchase, any communications with the manufacturer, and photographs of the product.
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Product Details
The recalled product is Diasol's 100425-10-DEX100 liquid concentrate for bicarbonate dialysis. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
Key Facts
- Safety and efficacy not assured
- Immediate stop-use advised
- Contact Diasol for instructions
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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