VANTIVE US HEALTHCARE LLC: Medical Device Recall in 2026 - (Recall #: Z-1231-2026)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2026.

Data Source: FDA.
Product Description:

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

Product Classification:

Class II

Date Initiated: January 6, 2026
Date Posted: February 11, 2026
Recall Number: Z-1231-2026
Event ID: 98180
Reason for Recall:

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

Status: Ongoing
Product Quantity: 13,760 units
Code Information:

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

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated