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 07332414069315, All lots including and manufactured after 24F0094CA
- 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 HF1000 SET is a medical device used in dialysis treatments, allowing patients to receive renal replacement therapy. Patients and healthcare providers rely on its functionality to ensure safe and effective dialysis procedures.
Why This Is Dangerous
The risk of dislodgement from the control unit can interrupt the dialysis process, which is critical for patients with kidney failure. This malfunction could lead to serious health complications, making the product hazardous.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects a large number of patients who depend on this medical device for regular dialysis treatments. Immediate action is necessary to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Verify the product code and model number against the recall notice.
- Check if the device is part of the affected lots manufactured after 24F0094CA.
- Contact your healthcare provider for assistance.
Where to find product info
Product codes and model numbers can typically be found on the device packaging or the product itself.
What timeline to expect
Expect a timeline of approximately 4-6 weeks for refund or replacement processing after contacting the manufacturer.
If the manufacturer is unresponsive
- Reach out again to VANTIVE US HEALTHCARE.
- Consider filing a complaint with the FDA if there's no response.
- Document all communications for your records.
How to prevent similar issues
- Check for FDA recalls before purchasing medical devices.
- Look for devices with safety certifications.
- Consider alternatives with proven reliability.
Documentation advice
Document all correspondence with the manufacturer, including emails and phone calls. Keep receipts and any return shipping information.
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Product Details
The recalled product is the PRISMAFLEX HF1000 SET, Product Code 107142. It includes all lots manufactured after 24F0094CA and has a UDI/DI of 07332414069315. The device was distributed nationwide in the United States.
Key Facts
- Potential dislodgement risk
- Class II recall
- Stop using the device immediately
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Safety Guide
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