Class IIOngoingZ-2274-2026
Fresenius Kabi USA, LLC recalls The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Potential for the Cassette Loading Lever to break.
Fresenius Kabi USA, LL…MAJun 10, 2026
Fresenius Kabi USA, LLC recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1–12 of 15 recalls
Class IOngoingZ-2224-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore r…
Fresenius Kabi USA, LL…MAJun 10, 2026
Class IOngoingZ-2223-2026
Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS)
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Fresenius Kabi USA, LL…MAJun 10, 2026
Class IIOngoingZ-1048-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Emphasizing instructions for LVP duration programming located in the IFU.
Fresenius Kabi USA, LL…MAJan 21, 2026
Class IOngoingZ-0885-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Fresenius Kabi USA, LL…MADec 24, 2025
Class IIOngoingZ-0848-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IOngoingZ-0586-2026
Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Fresenius Kabi USA, LL…MADec 10, 2025
Class IIOngoingZ-0378-2026
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS)
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Fresenius Kabi USA, LL…MANov 5, 2025
Class IIOngoingZ-2235-2025
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set
Potential for external cassette leaks
Fresenius Kabi USA, LL…MAAug 6, 2025
Class IIOngoingZ-2234-2025
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set
Potential for external cassette leaks
Fresenius Kabi USA, LL…MAAug 6, 2025
Class IIOngoingZ-2233-2025
Fresenius Kabi USA, LLC recalls LVP Blood Products Administration Set Dual-Inlet
Potential for external cassette leaks
Fresenius Kabi USA, LL…MAAug 6, 2025
Class IIOngoingZ-2232-2025
Fresenius Kabi USA, LLC recalls LVP Primary Administration Set
Potential for external cassette leaks
Fresenius Kabi USA, LL…MAAug 6, 2025