RegWardenFDA facility compliance records
Company

Fresenius Kabi AG

22 recall(s) on record — most severe on record: Class I.

Recalls by year

FDA actions on record by year2014: 1 recalls; 2022: 3 recalls; 2023: 3 recalls; 2024: 4 recalls; 2025: 8 recalls; 2026: 3 recalls1’14’15’16’17’18’19’20’213’223’234’248’253’26
  • Recalls (22)

Registered facilities (10)

Recalls & enforcement

20263 records
  • Class IOngoing2026-05-06
    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 remained in service. More specifically, drops or jarring on a…
  • Class IOngoing2026-05-06
    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.
  • Class IIOngoing2026-02-04
    Potential for the Cassette Loading Lever to break.
20258 records
  • Class IIOngoing2025-11-21
    Emphasizing instructions for LVP duration programming located in the IFU.
  • Class IOngoing2025-11-14
    Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
  • Class IIOngoing2025-11-03
    Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
  • Class IOngoing2025-11-03
    Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
  • Class IIOngoing2025-09-03
    Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
  • Class IIOngoing2025-06-24
    Potential for external cassette leaks
  • Class IOngoing2025-05-12
    Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter out large blood particulates.
  • Class IOngoing2025-01-10
    Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a p…
20244 records
  • Class IOngoing2024-12-06
    Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
  • Class IOngoing2024-08-30
    The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
  • Class IOngoing2024-08-01
    A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication overdose).
  • Class IOngoing2024-03-07
    Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
20233 records
  • Class IOngoing2023-11-29
    The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
  • Class IICompleted2023-05-10
    Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the c…
  • Class IOngoing2023-03-10
    Fluid ingress that can cause a loss of electrical funtion and failure of the Set ID Sensory, resulting in the prevention of infusion or halt of infusion.
20223 records
  • Class IICompleted2022-09-16
    Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and p…
  • Class ITerminated2022-09-08
    The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads t…
  • Class IIOngoing2022-04-22
    Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set
20141 record

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “Fresenius Kabi AG — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-9027285-fresenius-kabi-ag/

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