Class IIReported 2026-02-11

OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Recalled by VANTIVE US HEALTHCARE LLC

Reason for Recall

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

Recall Number

Z-1226-2026

Classification

Class II

Status

Ongoing

Category

device

Initiated

2026-01-06

Reported

2026-02-11

Distribution

US Nationwide distribution.

Code Info

UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z

Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.