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Recall database

Recalls: Component design/selection

Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.

Showing 49–54 of 54 recalls

Class IIOngoingZ-1228-2026

VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX M150 SET

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

VANTIVE US HEALTHCARE…ILFeb 11, 2026

Class IIOngoingZ-1227-2026

VANTIVE US HEALTHCARE LLC recalls PRIMSAFLEX M100 SET

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

VANTIVE US HEALTHCARE…ILFeb 11, 2026

Class IIOngoingZ-1226-2026

VANTIVE US HEALTHCARE LLC recalls OXIRIS SET

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

High Permeability With Or Without Sealed Dialysate System Dialyzer
Component design/selection

VANTIVE US HEALTHCARE…ILFeb 11, 2026

Class IIOngoingZ-1225-2026

VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST150 SET US

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

High Permeability With Or Without Sealed Dialysate System Dialyzer
Component design/selection

VANTIVE US HEALTHCARE…ILFeb 11, 2026

Class IIOngoingZ-1224-2026

VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX ST100 SET US

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

High Permeability With Or Without Sealed Dialysate System Dialyzer
Component design/selection

VANTIVE US HEALTHCARE…ILFeb 11, 2026

Class IIOngoingZ-1004-2026

Vortex Surgical Inc. recalls Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe

Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannula smoothly.

Photocoagulator And Accessories
Component design/selection

Vortex Surgical Inc.MOJan 7, 2026