Class II
Medical Device Recall: OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
VANTIVE US HEALTHCARE LLC · January 6, 2026
Reason for Recall
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
2,724 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1226-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.