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 07332414069254, All lots including and manufactured after 24G0034CA
- 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. Patients and healthcare providers purchase this product for its high permeability to ensure efficient blood filtration during procedures.
Why This Is Dangerous
The risk of dislodgement of the deaeration chamber from the control unit can lead to serious complications during dialysis. This malfunction may interrupt treatment and compromise patient safety.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device must stop using it immediately, which can disrupt their treatment. This recall requires urgent attention to prevent potential health risks.
Practical Guidance
How to identify if yours is affected
- Check your Prismaflex HF1000 Set model number against the recalled models.
- Confirm the product code is 107140 or check if manufactured after lot 24G0034CA.
- Look for any visible signs of dislodgement.
Where to find product info
The model number and product code can typically be found on the product packaging or on the device itself.
What timeline to expect
Expect a processing time of 4-6 weeks for refunds or replacements after the recall instructions are followed.
If the manufacturer is unresponsive
- Contact the manufacturer again for follow-up.
- Reach out to the FDA for additional guidance on recalls.
How to prevent similar issues
- Always check for recent recalls on medical devices before use.
- Consult with healthcare providers about device safety and alternatives.
- Be aware of potential hazards associated with medical devices.
Documentation advice
Document all communications with the manufacturer and keep a copy of recall notices and any receipts related to the device.
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Product Details
The recalled product is the Prismaflex HF1000 Set, Product Code 107140. It has UDI/DI 07332414069254 and includes all lots manufactured after 24G0034CA. The product was distributed nationwide in the U.S.
Key Facts
- Dislodgement risk from control unit
- Immediate stop-use action required
- No injuries reported as of recall date
- Contact manufacturer for instructions
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Safety Guide
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