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
- Dialysis Concentrate
- Model numbers
- UDI: None/Lot Code: PHV08081, PHV09042
- 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 100125-10-DEX100 is a liquid concentrate used in bicarbonate dialysis, a common treatment for patients with kidney failure. Patients buy this product to assist in their dialysis treatments, ensuring the proper balance of fluids and electrolytes in their bodies.
Why This Is Dangerous
The recall highlights concerns that the product may not perform effectively, which is critical for patients relying on dialysis for life-sustaining treatment. An ineffective concentrate could lead to serious health complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients who have used this dialysis concentrate may face health risks, making immediate cessation necessary. The recall impacts patient treatment plans and may require adjustments to ensure safe and effective dialysis.
Practical Guidance
How to identify if yours is affected
- Look for the product name 'Diasol 100125-10-DEX100' on the container.
- Check the lot codes PHV08081 or PHV09042 printed on the label.
- Confirm if you purchased the product between the specified distribution dates.
Where to find product info
Find the lot codes on the product label, typically near the expiration date or barcode.
What timeline to expect
Expect a refund process timeline of approximately 4-6 weeks after submitting your request.
If the manufacturer is unresponsive
- Document your communication attempts with Diasol.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Research the safety record of medical devices before purchasing.
- Consult with healthcare providers regarding alternative products.
- Review FDA recalls regularly to stay informed about medical device safety.
Documentation advice
Keep records of your purchase, including receipts and any communication with the manufacturer regarding the recall.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is Diasol's 100125-10-DEX100 liquid concentrate for bicarbonate dialysis. It was distributed nationwide in states including Missouri, California, Arizona, Texas, Illinois, and Massachusetts.
Key Facts
- Recall date: November 5, 2025
- Quantity recalled: 7,200 gallons
- Distribution: Nationwide in the U.S.
- Affected states: MO, CA, AZ, TX, IL, MA
- Classification: Class II
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.