The FDA has posted 15 enforcement recalls from Fresenius Kabi USA, LLC since 2025, including 7 Class I (most serious) recalls. Most recent report: Jun 10, 2026.
Potential for the Cassette Loading Lever to break.
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…
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.
Emphasizing instructions for LVP duration programming located in the IFU.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Potential for external cassette leaks
Potential for external cassette leaks
Potential for external cassette leaks
Potential for external cassette leaks
Firm name as filed with the FDA: “Fresenius Kabi USA, LLC”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.