Medical DeviceJan 21, 2026
Fresenius Kabi USA Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 recall — FDA Z-1048-2026
Emphasizing instructions for LVP duration programming located in the IFU.
Class IIFDA: OngoingFresenius Kabi USA, LLC
Recall history in this database
Classification mix: Class II: 50, Class I: 26, Class III: 6.
Medical DeviceDec 24, 2025
Fresenius Kabi USA Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA Z-0885-2026
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceDec 10, 2025
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump recall — FDA Z-0848-2026
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceDec 10, 2025
Fresenius Kabi USA IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet recall — FDA Z-0586-2026
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class IFDA: OngoingFresenius Kabi USA, LLC
DrugDec 3, 2025
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials recall — FDA D-0182-2026
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceAug 6, 2025
Fresenius Kabi USA LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free recall — FDA Z-2235-2025
Potential for external cassette leaks
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceAug 6, 2025
Fresenius Kabi USA LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free recall — FDA Z-2232-2025
Potential for external cassette leaks
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceAug 6, 2025
Fresenius Kabi USA LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25) recall — FDA Z-2234-2025
Potential for external cassette leaks
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceAug 6, 2025
Fresenius Kabi USA LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site recall — FDA Z-2233-2025
Potential for external cassette leaks
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceJun 18, 2025
Fresenius Kabi USA IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet recall — FDA Z-1869-2025
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.
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceFeb 12, 2025
Fresenius Kabi USA Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 recall — FDA Z-1019-2025
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…
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceJan 15, 2025
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump recall — FDA Z-0763-2025
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceOct 2, 2024
Fresenius Kabi USA Ivenix Infusion System (IIS), LVP Software recall — FDA Z-3153-2024
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 IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceSep 11, 2024
Fresenius Kabi USA LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free recall — FDA Z-2721-2024
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 IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceApr 17, 2024
Fresenius Kabi USA LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0 recall — FDA Z-1484-2024
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceMar 20, 2024
Fresenius Kabi USA LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 recall — FDA Z-1282-2024
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…
Class IIFDA: CompletedFresenius Kabi USA, LLC
Medical DeviceMar 20, 2024
Fresenius Kabi USA LVP software of the Ivenix Infusion System (IIS) recall — FDA Z-1283-2024
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…
Class IIFDA: CompletedFresenius Kabi USA, LLC
Medical DeviceDec 27, 2023
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 recall — FDA Z-0549-2024
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…
Class IFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceOct 4, 2023
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and recall — FDA Z-2635-2023
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…
Class IIFDA: OngoingFresenius Kabi USA, LLC
Medical DeviceApr 19, 2023
Fresenius Kabi USA Ivenix Infusion System (IIS), Large Volume Pump, Model No recall — FDA Z-1313-2023
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.
Class IFDA: OngoingFresenius Kabi USA, LLC
DrugJan 25, 2023
Sensorcaine recall — FDA D-0128-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class IIFDA: TerminatedFresenius Kabi USA, LLC
DrugJan 25, 2023
SENSORCAINE recall — FDA D-0129-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class IIFDA: TerminatedFresenius Kabi USA, LLC
DrugJan 25, 2023
Sensorcaine recall — FDA D-0127-2023
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class IIFDA: TerminatedFresenius Kabi USA, LLC
Medical DeviceOct 12, 2022
Fresenius Kabi USA Ivenix Infusion System (IIS), LVP Software recall — FDA Z-0002-2023
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…
Class IFDA: TerminatedFresenius Kabi USA, LLC
Understanding this recall history
This page summarizes recall records in which the official source identifies Fresenius Kabi USA, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.