Class IIOngoingZ-1230-2026
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX HF1000 SET
There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
VANTIVE US HEALTHCARE…ILFeb 11, 2026
Dialyzer, High Permeability With Or Without Sealed Dialysate System recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 15 recalls
Class IIOngoingZ-1229-2026
VANTIVE US HEALTHCARE LLC recalls PRISMAFLEX HF1000 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-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.
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.
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.
VANTIVE US HEALTHCARE…ILFeb 11, 2026
Class IIOngoingZ-0936-2026
Fresenius Medical Care Holdings, Inc. recalls 5008X CAREsystem +CLiC +CDX
Several software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if certain conditions are fulfilled.
Fresenius Medical Care…MADec 24, 2025
Class IIOngoingZ-0912-2026
Nipro Medical Corporation recalls Hemodialysis System
Screw may loosen or fallout of Hemodialysis system
Nipro Medical Corporat…FLDec 17, 2025
Class IIOngoingZ-2439-2025
VANTIVE US HEALTHCARE LLC recalls TherMax Blood Warmer Unit-US
Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit leading to difficulty setting up therapy, or PrisMax System alarm T2284: Thermax Disposable Not Inserted
VANTIVE US HEALTHCARE…ILSep 3, 2025
Class IIOngoingZ-2438-2025
VANTIVE US HEALTHCARE LLC recalls PrisMax V3 control Unit-US
Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or difficulty normalizing the Blood Leak Detector (BLD) leading to PrisMax System alarms T1313: BLD Normalize Failed, T0853: Norm…
VANTIVE US HEALTHCARE…ILSep 3, 2025
Class IIOngoingZ-2437-2025
VANTIVE US HEALTHCARE LLC recalls PrisMax V2-US
Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air Detected in Prime resulting in multiple additional priming cycles
VANTIVE US HEALTHCARE…ILSep 3, 2025