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 07332414064556, All lots including and manufactured after 24F0077CA
- 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 PRIMSAFLEX M100 Set is a medical device used in dialysis treatment, providing high permeability for effective filtration. Patients purchase these devices to manage kidney failure and ensure proper blood filtration during treatment.
Why This Is Dangerous
The potential dislodgement of the deaeration chamber can disrupt the dialysis process, posing serious risks to patient health. This malfunction could lead to inadequate treatment and potential medical complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall requires immediate action from patients and healthcare providers to prevent potential health risks. The urgency stems from the need for safe and effective dialysis treatment.
Practical Guidance
How to identify if yours is affected
- Check the product code on your PRIMSAFLEX M100 Set for the model number 106697.
- Verify if your device is manufactured after 24F0077CA.
- Look for notifications from VANTIVE US HEALTHCARE regarding the recall.
Where to find product info
The product code and model number are typically located on the packaging and the device itself.
What timeline to expect
Expect further instructions regarding the refund or replacement process within 4-8 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication attempts with VANTIVE US HEALTHCARE.
- Consider contacting the FDA or your healthcare provider for assistance.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that medical devices are from reputable manufacturers with good safety records.
- Consult with healthcare professionals regularly about your medical devices.
Documentation advice
Keep records of your purchase, any communications with the manufacturer, and a copy of the recall notification for your files.
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Product Details
The recall involves the PRIMSAFLEX M100 Set, Product Code 106697, which includes all lots manufactured after 24F0077CA. The product is distributed nationwide in the United States.
Key Facts
- Recall date: January 6, 2026
- Quantity recalled: 230,596 units
- Class II recall classification
- Nationwide distribution in the US
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Safety Guide
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