Fresenius Kabi USA, LLC Recalls

All product recalls associated with Fresenius Kabi USA, LLC.

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Recall Summary

Total Recalls

16

Past Year

9

Class I (Serious)

1

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–16 of 16 recalls

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. S... (Fresenius Kabi USA, LLC) – software version 5 (2025)

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.

Very High

FDANov 14, 2025CA, CO, FL +17 more• Fresenius Kabi USA, LLC

Famotidine Injection (Fresenius Kabi) – microbial contamination (2025)

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.

Class IModerate

FDANov 6, 2025Nationwide• Fresenius Kabi USA, LLC

IVENIX Infusion System (Fresenius Kabi) – incorrect assembly (2025)

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.

Moderate

FDA

Nov 3, 2025

Nationwide

• Fresenius Kabi USA, LLC

Ivenix Infusion System (Fresenius Kabi) – downstream occlusion (2025)

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.

Moderate

FDANov 3, 2025Nationwide• Fresenius Kabi USA, LLC

Ivenix Infusion System (Fresenius Kabi) – Touchscreen Error (2025)

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

High

FDASep 3, 2025Nationwide• Fresenius Kabi USA, LLC

LVP Primary Administration Set (Fresenius Kabi) – Cassette Leak (2025)

Potential for external cassette leaks

FDAJun 24, 2025Nationwide• Fresenius Kabi USA, LLC

LVP Blood Products Set (Fresenius Kabi) – Cassette Leak (2025)

Potential for external cassette leaks

FDAJun 24, 2025Nationwide• Fresenius Kabi USA, LLC

Ivenix Infusion System Set (Fresenius Kabi) – Filter Positioning (2025)

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.

FDAMay 12, 2025CA, CO, DE +15 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. ...

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 primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

FDAJan 10, 2025CA, CO, GA +12 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump, Model Nu...

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

FDADec 6, 2024ID, MN, NV +3 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, ...

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.

FDAAug 30, 2024Nationwide• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, ...

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).

FDAAug 1, 2024CO, ID, NJ +1 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: LVP Software of the Ivenix Infusion System (IIS), Version...

Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.

FDAMar 7, 2024CA, CO, ID +10 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump LVP-0004

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.

FDANov 29, 2023CA, CO, NJ +2 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump, Model No...

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.

FDAMar 10, 2023CA, CO, NJ +2 more• Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC: Ivenix Infusion System (IIS), Large Volume Pump (LVP) Sof...

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

FDAApr 22, 2022Nationwide• Fresenius Kabi USA, LLC

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