Vantive US Healthcare Recalls PRISMAFLEX M150 Sets Due to Deaeration Chamber Issues

Source: FDA · United States

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Vantive US Healthcare LLC has initiated a voluntary recall of over 137,000 PRISMAFLEX M150 Sets due to a risk of the deaeration chamber dislodging from the control unit.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 18, 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 regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who 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 read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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What Happened

Vantive US Healthcare LLC has initiated a voluntary recall of the PRISMAFLEX M150 SET. The recall was prompted by the discovery of a potential defect where the Prismaflex Set deaeration chamber may dislodge from the Prismaflex Control Unit. The FDA has classified this as a Class II recall.

Which Products Are Affected

The recall involves approximately 137,576 units distributed nationwide across the United States. Affected products include:

  • Product Name: PRISMAFLEX M150 SET (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
  • Product Code: 109990
  • UDI/DI: 07332414090005
  • Lot Information: All lots including and manufactured after 24F0100CA
  • Recall Number: Z-1228-2026

What You Should Do

Vantive US Healthcare LLC began notifying affected customers via a formal letter on January 6, 2026. Healthcare facilities and providers should immediately check their inventory for the specified lot numbers. For additional information or instructions regarding the return of affected units, contact Vantive US Healthcare LLC at their Deerfield, Illinois office located at 510 Lake Cook Rd.

Why This Matters

The dislodgement of the deaeration chamber during medical procedures could lead to therapy interruptions or other clinical complications. A Class II classification indicates that while the probability of serious adverse health consequences is remote, the product may cause temporary or medically reversible health issues.

Source

Information provided by the FDA under event ID 98180.

Original source: FDA Official Notice ↗

All FDA Recalls →

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Vantive US Healthcare LLC has initiated a voluntary recall of over 137,000 PRISMAFLEX M150 Sets due to a risk of the deaeration chamber dislodging from the control unit.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.