Fresenius Kabi Usa recalls
Fresenius Kabi Usa appears in 95 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-02.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 95 |
|---|---|
| Published | 2013-07-17 to 2026-09-02 |
| By agency | FDA Drug (70), FDA Device (25) |
| By classification | Class II (57), Class I (26), Class III (12) |
| By status | terminated (49), ongoing (44), completed (2) |
| Distribution named in notices | CA, CO, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NC, NE, NJ, NV, OK, OR, SC, TX, US, UT, VA, WA, WI |
Recalls
- Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Il…
FDA Drug · Class I · 2026-09-02 · Fresenius Kabi Usa
Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles. - Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fre…
FDA Drug · Class I · 2026-08-26 · Fresenius Kabi Usa
Reason: Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. - Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Hair was found in products - Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Hair was found in products - Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Hair was found in product - Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fr…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Hair was found in products - Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, La…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
Reason: Presence of Particulate Matter: Hair was found in products - Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 633…
FDA Drug · Class III · 2026-06-17 · Fresenius Kabi Usa
Reason: Failed Impurities/Degradations Specifications - LVP software of the Ivenix Infusion System (IIS)
FDA Device · Class I · 2026-06-10 · Fresenius Kabi Usa
Reason: 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. - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Device · Class I · 2026-06-10 · Fresenius Kabi Usa
Reason: 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… - The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004
FDA Device · Class II · 2026-06-10 · Fresenius Kabi Usa
Reason: Potential for the Cassette Loading Lever to break. - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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,…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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 an…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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, L…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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"), Un…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - 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: Fr…
FDA Drug · Class II · 2026-04-15 · Fresenius Kabi Usa
Reason: Lack of Assurance of Sterility - Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005
FDA Device · Class II · 2026-01-21 · Fresenius Kabi Usa
Reason: Emphasizing instructions for LVP duration programming located in the IFU. - Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
FDA Device · Class I · 2025-12-24 · Fresenius Kabi Usa
Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. - Ivenix Infusion System (IIS), Large Volume Pump
FDA Device · Class II · 2025-12-10 · Fresenius Kabi Usa
Reason: Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. - IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
FDA Device · Class I · 2025-12-10 · Fresenius Kabi Usa
Reason: Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury. - 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), 633…
FDA Drug · Class I · 2025-12-03 · Fresenius Kabi Usa
Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. - Ivenix Infusion System (IIS), Large Volume Pump
FDA Device · Class II · 2025-11-05 · Fresenius Kabi Usa
Reason: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation. - LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa
Reason: Potential for external cassette leaks - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa
Reason: Potential for external cassette leaks - LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa
Reason: Potential for external cassette leaks - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25)
FDA Device · Class II · 2025-08-06 · Fresenius Kabi Usa
Reason: Potential for external cassette leaks - IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intravascular Administra…
FDA Device · Class I · 2025-06-18 · Fresenius Kabi Usa
Reason: 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. - Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
FDA Device · Class I · 2025-02-12 · Fresenius Kabi Usa
Reason: 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. I… - Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
FDA Device · Class I · 2025-01-15 · Fresenius Kabi Usa
Reason: Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used. - Ivenix Infusion System (IIS), LVP Software
FDA Device · Class I · 2024-10-02 · Fresenius Kabi Usa
Reason: 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. - LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. for intravenous infu…
FDA Device · Class I · 2024-09-11 · Fresenius Kabi Usa
Reason: 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). - LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0
FDA Device · Class I · 2024-04-17 · Fresenius Kabi Usa
Reason: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death. - LVP software of the Ivenix Infusion System (IIS)
FDA Device · Class II · 2024-03-20 · Fresenius Kabi Usa
Reason: 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… - LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
FDA Device · Class II · 2024-03-20 · Fresenius Kabi Usa
Reason: 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)… - Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
FDA Device · Class I · 2023-12-27 · Fresenius Kabi Usa
Reason: 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/… - Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004
FDA Device · Class II · 2023-10-04 · Fresenius Kabi Usa
Reason: 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… - Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
FDA Device · Class I · 2023-04-19 · Fresenius Kabi Usa
Reason: 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. - Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa
Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. - Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg pe…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa
Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. - Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per m…
FDA Drug · Class II · 2023-01-25 · Fresenius Kabi Usa
Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. - Ivenix Infusion System (IIS), LVP Software
FDA Device · Class I · 2022-10-12 · Fresenius Kabi Usa
Reason: 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 n…