Vantive US Healthcare Recalls Oxiris Set Dialyzers Due to Chamber Dislodgement Risk
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Vantive US Healthcare LLC has issued a voluntary recall for 2,724 Oxiris Set dialyzers because the deaeration chamber may dislodge from the control unit.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, MedicalDevices.
What Happened
Vantive US Healthcare LLC has initiated a voluntary recall of the Oxiris Set dialyzer system. The recall was prompted by the discovery of a potential defect where the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit during use.
Which Products Are Affected
The recall involves the following medical device:
- Product Name: OXIRIS SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 112016
- Recall Number: Z-1226-2026
- UDI/DI: 07332414102234
- Lot Information: All lots including and manufactured after 24G0041Z
- Quantity: 2,724 units
- Distribution: Distributed nationwide across the United States.
What You Should Do
The recalling firm, Vantive US Healthcare LLC, initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers in possession of these units should follow the specific instructions provided in the firm's notification letter regarding the inspection or return of the affected sets. For further inquiries, contact Vantive US Healthcare LLC at their Deerfield, Illinois location.
Why This Matters
This Class II recall indicates that the use of the affected product may cause temporary or medically reversible adverse health consequences. A dislodged deaeration chamber could lead to treatment interruptions or other complications during critical dialysis procedures.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
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