Quick Facts at a Glance
- Recall Date
- January 6, 2026
- Hazard Level
- HIGH
- Brand
- VANTIVE US HEALTHCARE
- 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
- VANTIVE US HEALTHCARE
- Product type
- Dialyzer
- Model numbers
- UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 6, 2026
Reported by FDA DEVICE
February 11, 2026
RecallRadar source check
February 18, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact VANTIVE US HEALTHCARE LLC or your healthcare provider for instructions. Notification method: Letter
About This Product
The Prismaflex M150 Set is a medical device used in dialysis treatment for patients with kidney failure. It facilitates the removal of waste and excess fluid from the bloodstream during dialysis procedures.
Why This Is Dangerous
The potential dislodgement of the deaeration chamber from the control unit can compromise the device's functionality, posing serious health risks to patients relying on dialysis treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the Prismaflex M150 Set may face serious health risks if the device malfunctions during treatment, highlighting the urgency for immediate action.
Practical Guidance
How to identify if yours is affected
- Check the product code on your Prismaflex M150 Set to verify if it's 109990.
- Look for the UDI/DI number, which should be 07332414090005.
- Confirm the manufacturing date is after 24F0100CA.
Where to find product info
The product code and UDI/DI number can typically be found on the packaging or the product label itself.
What timeline to expect
Expect the refund or replacement process to take approximately 4-8 weeks from the time your request is processed.
If the manufacturer is unresponsive
- Document all correspondence with VANTIVE US Healthcare.
- Reach out to the FDA if the company does not respond in a timely manner.
- Consider reporting the issue through appropriate consumer safety channels.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Look for FDA approval and safety certifications when purchasing healthcare products.
- Stay informed about updates from manufacturers regarding product safety.
Documentation advice
Keep a record of all communication with VANTIVE US Healthcare, including emails, letters, and phone call notes.
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Product Details
The recalled product is the Prismaflex M150 Set, Product Code 109990, with UDI/DI 07332414090005. The recall affects all lots manufactured after 24F0100CA. The devices were distributed nationwide in the U.S.
Key Facts
- Recall date: January 6, 2026
- Reported date: February 11, 2026
- Hazard level: High
- Quantity recalled: 137,576 units
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Safety Guide
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