Recall archive
61 recalls · page 1 of 3
Reported Sep 2, 2026Updated Sep 7, 2026
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
FDA (openFDA drug enforcement)
Reported Aug 26, 2026Updated Sep 7, 2026
Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
FDA (openFDA drug enforcement)
Reported Jul 29, 2026
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…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Presence of Particulate Matter: Hair was found in product
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Jun 17, 2026
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Failed Impurities/Degradations Specifications
FDA (openFDA drug enforcement)
Reported Jun 10, 2026
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 15, 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,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Lack of Assurance of Sterility
13 more products in this recall
FDA (openFDA drug enforcement)
Reported Jan 21, 2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Emphasizing instructions for LVP duration programming located in the IFU.
FDA (openFDA device enforcement)
Reported Dec 24, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
FDA (openFDA device enforcement)
Reported Dec 10, 2025
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 3, 2025
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
FDA (openFDA drug enforcement)
Reported Nov 7, 2025Updated Aug 26, 2026
Fresenius Kabi USA, LLC recalls Fresenius Kabi Famotidine Injection, USP 20 mg per 2 mL due to Out-of-specification endotoxin results
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.Fresenius Kabi USA, LLC
Matched: Brand · Product · Product details — Out-of-specification endotoxin results
FDA (recalls & safety alerts)
Reported Nov 5, 2025
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA (openFDA device enforcement)
Reported Aug 6, 2025
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Potential for external cassette leaks
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 18, 2025
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Mis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter…
FDA (openFDA device enforcement)
Reported Feb 12, 2025
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jan 15, 2025
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
FDA (openFDA device enforcement)
Reported Oct 2, 2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could…
FDA (openFDA device enforcement)
Reported Sep 11, 2024
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25.…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — A defect may cause an uncontrolled medication flow condition which may result in a dose greater than prescribed for the patient (i.e., medication…
FDA (openFDA device enforcement)
Reported Apr 17, 2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
FDA (openFDA device enforcement)
Reported Mar 20, 2024
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Oct 4, 2023
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. Indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Apr 19, 2023
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
High riskUsing this product could cause serious injury, illness or death — stop using it now.Fresenius Kabi USA, LLC
Matched: Brand — 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…
FDA (openFDA device enforcement)
Reported Jan 25, 2023
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Fresenius Kabi USA, LLC
Matched: Brand · Product details — Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
2 more products in this recall
FDA (openFDA drug enforcement)
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