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 07332414111038, All lots including and manufactured after 24J0106
- 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 TPE2000 Set is a medical device used in dialysis treatments. Healthcare providers and patients rely on this product for its high permeability features in managing patients' renal health.
Why This Is Dangerous
The hazard arises from the potential dislodgement of the deaeration chamber from the control unit, which could disrupt the dialysis process and pose serious health risks to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the Prismaflex TPE2000 Set may face serious health risks if the device malfunctions. The urgency of the recall requires immediate action to ensure patient safety.
Practical Guidance
How to identify if yours is affected
- Check the product code 114093.
- Verify the model number against the recall information.
- Confirm if the device was manufactured after lot number 24J0106.
Where to find product info
Look for the product code on the packaging and the device itself, typically located on a label or barcode.
What timeline to expect
Allow 4-6 weeks for processing refunds or replacements after following the recall instructions.
If the manufacturer is unresponsive
- Document all communications with VANTIVE US HEALTHCARE.
- Contact consumer protection agencies for further assistance.
- Consider consulting a lawyer if serious health issues arise.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Consult with healthcare providers about the latest device safety information.
- Purchase medical supplies from reputable suppliers.
Documentation advice
Keep copies of correspondence with the manufacturer, receipts, and any related medical records.
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Product Details
The recalled product is the Prismaflex TPE2000 Set, Product Code 114093. It includes models UDI/DI 07332414111038 and all lots manufactured after 24J0106. The product was distributed nationwide in the U.S.
Key Facts
- High permeability dialyzer
- Potential dislodgement hazard
- Stop use immediately
- Contact healthcare provider for guidance
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Safety Guide
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