CLASS II ONGOING Device recall · Reported 11 Feb 2026 · FDA Enforcement Report

Prismaflex Tpe2000 Set recalled by Vantive Us Healthcare

Vantive US Healthcare is recalling Prismaflex Tpe2000 Set, distributed nationwide in the US. The recall was initiated on 6 Jan 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI/DI 07332414111038, All lots including and manufactured after 24J0106

Quantity recalled13,760 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1231-2026
FDA event ID: 98180
Recalling firm: Vantive US Healthcare, Deerfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 6 Jan 2026
FDA classified: 2 Feb 2026
Reported: 11 Feb 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

6 Jan 2026	Recall initiated by company
2 Feb 2026	Classified by FDA	+27 days
11 Feb 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Why was it recalled?

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.

Which lots are affected?

UDI/DI 07332414111038, All lots including and manufactured after 24J0106

Where was it sold?

US Nationwide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 98180

This product is part of a recall event; the main page for the event is Primsaflex M100 Set recalled by Vantive Us Healthcare.

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026	CLASS II	Primsaflex M100 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026	CLASS II	Prismaflex St100 Set Us recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026	CLASS II	Oxiris SET recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026	CLASS II	Prismaflex M150 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026	CLASS II	Prismaflex Hf1000 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026	CLASS II	Prismaflex St150 Set Us recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026	CLASS II	Prismaflex Hf1000 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide

More recalls from Vantive US Healthcare

All 12

Reported	Class	Recall	Company	Reason	Where
11 Feb 2026Device	CLASS II	Prismaflex Hf1000 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026Device	CLASS II	Prismaflex St150 Set Us recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026Device	CLASS II	Prismaflex Hf1000 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026Device	CLASS II	Prismaflex M150 Set recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide
11 Feb 2026Device	CLASS II	Oxiris SET recalled by Vantive Us Healthcare	Vantive US Healthcare	Packaging Defects	Nationwide

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All 13,778

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16 Sep 2026Device	CLASS II	AMS Convenience Kit: Dsaek Pack - RX recalled	Windstone Medical Packaging	Device Malfunction	Nationwide