OXIRIS SET recall (VANTIVE US HEALTHCARE LLC)
Medical deviceClass IIOngoing
Summary: VANTIVE US HEALTHCARE LLC is recalling OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System. Reason: There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
What is being recalled
OXIRIS SET, Product Code 112016; Dialyzer, High Permeability With Or Without Sealed Dialysate System
Why
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution.
How to tell if yours is affected
UDI/DI 07332414102234, All lots including and manufactured after 24G0041Z
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1226-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | January 6, 2026 |
| Reported | February 11, 2026 |
| Company | VANTIVE US HEALTHCARE LLC |
| Company location | Deerfield, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 2,724 units |
More recalls from VANTIVE US HEALTHCARE LLC · all medical device recalls · recalls from January 2026