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Fresenius Kabi USA, LLC
Fresenius Kabi USA, LLC: 25 FDA recall reports
Every medical device recall the FDA has published for Fresenius Kabi USA, LLC. The fault, and how the agency graded it.
25Reports
13Class I
21Ongoing
2026-06-10Most recent
13 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Z-2274-2026 · Class II · reported 2026-06-10 · Ongoing
- Why it was recalled
- Potential for the Cassette Loading Lever to break.
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
- Where it went
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- How much
- 18,444 installed bases
Class I
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Z-2223-2026 · Class I · reported 2026-06-10 · Ongoing
- Why it was recalled
- 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.
- Product
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Where it went
- US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- How much
- 32 systems
Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Z-2224-2026 · Class I · reported 2026-06-10 · Ongoing
- Why it was recalled
- 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 hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Where it went
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- How much
- 18,444
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Z-1048-2026 · Class II · reported 2026-01-21 · Ongoing
- Why it was recalled
- Emphasizing instructions for LVP duration programming located in the IFU.
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Where it went
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
- How much
- 30 units
Class I
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids t
Z-0885-2026 · Class I · reported 2025-12-24 · Ongoing
- Why it was recalled
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Where it went
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- How much
- 30 units
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Z-0848-2026 · Class II · reported 2025-12-10 · Ongoing
- Why it was recalled
- Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Where it went
- US Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, UT, VA, WA, WI.
- How much
- 15,862 units
Class I
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site
Z-0586-2026 · Class I · reported 2025-12-10 · Ongoing
- Why it was recalled
- Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Product
- IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.
- Where it went
- US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.
- How much
- 483 cases (12,075 eaches)
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Z-0378-2026 · Class II · reported 2025-11-05 · Ongoing
- Why it was recalled
- Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Where it went
- US Nationwide distribution in the state of Minnesota.
- How much
- 6 units
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code:
Z-2235-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- Potential for external cassette leaks
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
- Where it went
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- How much
- 348,150 units
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-
Z-2232-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- Potential for external cassette leaks
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
- Where it went
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- How much
- 19,225 units
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Z-2234-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- Potential for external cassette leaks
- Product
- LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
- Where it went
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- How much
- 35,925 units
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET
Z-2233-2025 · Class II · reported 2025-08-06 · Ongoing
- Why it was recalled
- Potential for external cassette leaks
- Product
- LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
- Where it went
- US Nationwide distribution in the states of CA, CO, DE, FL, GA, ID, IL, MA, MD, MI, MN, MS, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- How much
- 14,280 units
Class I
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15
Z-1869-2025 · Class I · reported 2025-06-18 · Ongoing
- Why it was recalled
- 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.
- Product
- IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
- Where it went
- US distribution: CA, CO, DE, GA, IL, MD, MI, MN, MS, NC, NJ, NV, OK, SC, TX, VA, WA & WI.
- How much
- 14,280 units (724 cases)
Class I
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient c
Z-1019-2025 · Class I · reported 2025-02-12 · Ongoing
- Why it was recalled
- 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.
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
- Where it went
- US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
- How much
- 23 systems
Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Z-0763-2025 · Class I · reported 2025-01-15 · Ongoing
- Why it was recalled
- Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Where it went
- US distribution to states of: ID, MN, NV, TX, VA, WI.
- How much
- 1,520 units
Class I
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump soft
Z-3153-2024 · Class I · reported 2024-10-02 · Ongoing
- Why it was recalled
- 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.
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
- Where it went
- US Nationwide.
- How much
- 17 units
Class I
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-
Z-2721-2024 · Class I · reported 2024-09-11 · Ongoing
- Why it was recalled
- 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).
- Product
- LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
- Where it went
- US Distribution to states of: CO, ID, NJ, UT.
- How much
- 180 cases/4,500 pieces
Class I
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Z-1484-2024 · Class I · reported 2024-04-17 · Ongoing
- Why it was recalled
- Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
- Product
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Where it went
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- How much
- 17 units
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Z-1282-2024 · Class II · reported 2024-03-20 · Completed
- Why it was recalled
- 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 patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
- Product
- LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
- Where it went
- US Nationwide distribution in the states of WI and NJ.
- How much
- 3
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Z-1283-2024 · Class II · reported 2024-03-20 · Completed
- Why it was recalled
- 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 clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.
- Product
- LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
- Where it went
- US Nationwide distribution to the states of CA, CO, NJ, WI, UT.
- How much
- 6 US
Class I
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Z-0549-2024 · Class I · reported 2023-12-27 · Ongoing
- Why it was recalled
- 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.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
- Where it went
- US distribution to states of: CA, CO, NJ, UT, and WI.
- How much
- 938 US
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004.
Z-2635-2023 · Class II · reported 2023-10-04 · Ongoing
- Why it was recalled
- 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
- Product
- Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
- Where it went
- US Nationwide distribution in the states of NJ, WI.
- How much
- 1344 pumps
Class I
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Z-1313-2023 · Class I · reported 2023-04-19 · Ongoing
- Why it was recalled
- 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.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
- Where it went
- Domestic: CA, CO, NJ, WI, & UT. No foreign distribution.
- How much
- 1,546 units
Class I
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Z-0002-2023 · Class I · reported 2022-10-12 · Terminated
- Why it was recalled
- 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 to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
- Where it went
- Domestic distribution to NJ and WI.
- How much
- 4 instances
HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial
Z-1032-2015 · Class II · reported 2015-02-04 · Terminated
- Why it was recalled
- The lot failed pH specification.
- Product
- HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710
- Where it went
- Nationwide Distribution
- How much
- Domestic: 69,725
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls