Quick Facts at a Glance
- Recall Date
- January 6, 2026
- Hazard Level
- HIGH
- Brand
- VANTIVE US HEALTHCARE
- Category
- Health & Personal Care
- Sold At
- Unknown
- 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 07332414102234, All lots including and manufactured after 24G0041Z
- Sold at
- Unknown
- 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 OXIRIS SET is a medical device used in dialysis treatments. Patients rely on it for effective filtration of blood during kidney replacement therapy.
Why This Is Dangerous
The defect can potentially dislodge the deaeration chamber, which could disrupt the dialysis process and lead to serious health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the OXIRIS SET must stop its use immediately, which may cause inconvenience and require alternative arrangements for dialysis.
Practical Guidance
How to identify if yours is affected
- Check the product code on your OXIRIS SET for 112016.
- Verify the UDI/DI number is 07332414102234.
- Consult your healthcare provider for further identification steps.
Where to find product info
Look for the product code and UDI number on the packaging or the device itself.
What timeline to expect
Expect processing for refunds or replacements to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Contact VANTIVE US HEALTHCARE directly via their customer service line.
- Document all communications regarding the recall.
How to prevent similar issues
- Look for devices with updated safety certifications.
- Check for recalls and safety alerts before purchasing medical devices.
- Consult healthcare professionals for recommendations on safe products.
Documentation advice
Keep a record of your purchase, including receipts, and document any communications with the manufacturer.
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Product Details
The recall affects the OXIRIS SET, Product Code 112016, which includes models with UDI/DI 07332414102234. The product was distributed nationwide in the United States.
Key Facts
- Recall date: January 6, 2026
- Active recall status
- Class II recall classification
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Safety Guide
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