Fresenius Kabi USA, LLC Recalls
32 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.
Medical Device Recalls (17)
- Class II
November 21, 2025
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Emphasizing instructions for LVP duration programming located in the IFU.
- Class I
November 14, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Class II
November 3, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
- Class I
November 3, 2025
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.
Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
- Class II
September 3, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
- Class II
June 24, 2025
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Potential for external cassette leaks
- Class II
June 24, 2025
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.
Potential for external cassette leaks
- Class II
June 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032-25.
Potential for external cassette leaks
- Class II
June 24, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Potential for external cassette leaks
- Class I
May 12, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administration Set.
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 I
January 10, 2025
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 r
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.
- Class I
December 6, 2024
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
- Class I
August 30, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
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 I
August 1, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infusion.
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 I
March 7, 2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
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 II
May 10, 2023
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
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.
- Class II
September 16, 2022
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
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.
Drug Recalls (15)
- Class II
March 11, 2026
5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-4
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 600047, Unit of Use ND
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 6
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-466-05, Unit of Sale
Lack of Assurance of Sterility
- Class II
March 11, 2026
5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical C
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distribut
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 6
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use N
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Dist
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distribu
Lack of Assurance of Sterility
- Class II
March 11, 2026
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of U
Lack of Assurance of Sterility
- Class II
March 11, 2026
5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-
Lack of Assurance of Sterility
- Class I
November 6, 2025
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.