FDAClass IIFebruary 11, 2026

Prismaflex M150 SET recall

PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Why was Prismaflex M150 SET recalled?

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI 07332414090005, All lots including and manufactured after 24F0100CA

Product
PRISMAFLEX M150 SET, Product Code 109990; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Recalling firm
VANTIVE US HEALTHCARE LLC
Quantity
137,576 units
Distribution
US Nationwide distribution.
Recall date
February 11, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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