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 00085412917696, All lots including and manufactured after 24F0085
- 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 ST150 SET US is a medical device used in dialysis treatment to filter waste from the blood. Patients require this type of equipment for routine kidney dialysis.
Why This Is Dangerous
The risk of dislodgement poses a serious safety concern, as it may interrupt the dialysis process and endanger patient health. Immediate action is necessary to prevent potential complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device for dialysis may face significant health risks if the device malfunctions, necessitating immediate action and alternative arrangements.
Practical Guidance
How to identify if yours is affected
- Verify product code and model number on the device.
- Check for the manufacturing date to see if it falls after the specified lot numbers.
- Contact your healthcare provider to confirm if your device is affected.
Where to find product info
Product codes are typically found on the device packaging or the device itself, often near the barcode or user manual.
What timeline to expect
Expect a refund or replacement process to take 4-8 weeks after the manufacturer processes your request.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Consider filing a complaint with the FDA if you receive no response.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that any medical equipment you purchase has the necessary safety certifications.
- Stay informed about product safety alerts from manufacturers and regulatory agencies.
Documentation advice
Keep records of your purchase, any correspondence related to the recall, and photographs of the device.
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Product Details
The recalled product is the PRISMAFLEX ST150 SET US, Product Code 107640US. It includes all lots manufactured after 24F0085. The devices were distributed nationwide in the United States.
Key Facts
- Potential dislodgement hazard
- High hazard classification
- Stop using the device immediately
- Contact manufacturer 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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