Vantive US Healthcare Recalls Prismaflex ST150 Sets Due to Chamber Dislodgement Risk

Source: FDA · United States

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Vantive US Healthcare LLC is recalling 264,040 Prismaflex ST150 Sets because the deaeration chamber may dislodge from the control unit, potentially impacting dialysis procedures.

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 ST150 Set. The recall was prompted by the discovery of a potential mechanical issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during operation.

Which Products Are Affected

The recall involves the following medical device:

  • Product Name: PRISMAFLEX ST150 SET US (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
  • Product Code: 107640US
  • UDI/DI: 00085412917696
  • Lot Information: All lots including and manufactured after 24F0085
  • Quantity: 264,040 units
  • Distribution: Nationwide across the United States

What You Should Do

Vantive US Healthcare LLC initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers currently using these sets should review their inventory for the affected lot numbers. For specific instructions regarding the continued use or return of these devices, contact Vantive US Healthcare LLC at their headquarters in Deerfield, Illinois.

Why This Matters

This recall is classified as a Class II event by the FDA. The dislodgement of the deaeration chamber from the control unit could lead to interruptions in dialysis treatment or other procedural complications, though the probability of serious adverse health consequences is considered remote.

Source

Information provided by the FDA under Recall Number Z-1225-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Vantive US Healthcare LLC is recalling 264,040 Prismaflex ST150 Sets because the deaeration chamber may dislodge from the control unit, potentially impacting dialysis procedures.
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.