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 00085412954073, All lots including and manufactured after 24G0072
- 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 ST100 Dialyzer is a medical device used in dialysis treatments for patients with kidney failure. It helps filter waste and excess fluids from the blood, making it critical for patient health.
Why This Is Dangerous
The potential dislodgement of the deaeration chamber can disrupt the functioning of the dialysis system, which may result in inadequate treatment for the patient.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this device for safe and effective dialysis are at risk if the device malfunctions. Immediate action is necessary to prevent potential health complications.
Practical Guidance
How to identify if yours is affected
- Check the product code: 107636US.
- Verify the model numbers against the recall notice.
- Consult healthcare providers for assistance in identifying affected units.
Where to find product info
Product codes and model numbers are typically located on the packaging or the device itself.
What timeline to expect
Expect a response from VANTIVE US HEALTHCARE regarding the recall within a few weeks after reporting.
If the manufacturer is unresponsive
- Follow up with VANTIVE US HEALTHCARE via phone or email.
- Document all communication attempts for your records.
How to prevent similar issues
- Always verify the safety and recall status of medical devices before use.
- Check for any updates from manufacturers or healthcare providers regarding medical devices.
Documentation advice
Keep records of your device's serial numbers, any correspondence with the manufacturer, and receipts if applicable.
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Product Details
The recalled product is the Prismaflex ST100 Set US, Product Code 107636US. It has been distributed nationwide in the U.S. and was sold in various healthcare facilities.
Key Facts
- Recall date: January 6, 2026
- Quantity recalled: 87,436 units
- Distribution: US Nationwide
- Risk level: High
- Classification: Class II
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Safety Guide
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