Vantive US Healthcare Recalls Prismaflex ST100 Sets Due to Chamber Dislodgement Risk
According to the U.S. Census Bureau's American Community Survey (ACS) 5-year estimates, the CDC PLACES population-level health analysis, and the CMS Hospital Compare quality data, Areazine publishes editorial articles drawing on more than 19,000 U.S. city profiles. See our methodology for full source attribution and refresh cadence.
Vantive US Healthcare LLC is recalling 87,436 Prismaflex ST100 Sets because the deaeration chamber may dislodge from the control unit, potentially disrupting dialysis treatment.
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.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (recall, product-safety, fda, MedicalDevice) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What Happened
Vantive US Healthcare LLC has initiated a voluntary recall of the Prismaflex ST100 Set. The recall was issued due to a potential issue where the deaeration chamber of the set may dislodge from the Prismaflex Control Unit during operation.
Which Products Are Affected
The recall affects the following medical device:
- Product Name: PRISMAFLEX ST100 SET US (Dialyzer, High Permeability With Or Without Sealed Dialysate System)
- Product Code: 107636US
- UDI/DI: 00085412954073
- Lot Information: All lots including and manufactured after 24G0072
- Quantity: 87,436 units
- Recall Number: Z-1224-2026
These products were distributed nationwide across the United States.
What You Should Do
The firm initiated the recall process on January 6, 2026, via a notification letter to affected customers. Healthcare facilities and providers should identify any affected stock from the specified lots. For instructions regarding the management of affected units or to report issues, contact Vantive US Healthcare LLC at their headquarters located at 510 Lake Cook Rd, Deerfield, IL 60015-4964.
Why This Matters
A dislodged deaeration chamber can lead to interruptions in dialysis therapy. The FDA has classified this as a Class II recall, indicating that the use of the product may cause temporary or medically reversible adverse health consequences.
Source
Information provided by the FDA.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Frequently Asked Questions
Common questions about this FDA recall.
What is this FDA recall about? ▾
Which agency issued this alert? ▾
How severe is this alert? ▾
What area is affected? ▾
Where can I find more FDA Recalls updates? ▾
Primary source data
EPA Outdoor Air Quality Data
Federal monitoring network — every measurement we report
AirNow (EPA / NOAA)
Real-time AQI for every monitored U.S. location
National Weather Service
Active watches, warnings, and advisories — NOAA
CDC Air Quality & Health
Health-impact reference behind every AQI category