Fresenius Kabi Usa, Llc
North Andover, MA
This page shows every FDA and USDA recall linked to Fresenius Kabi Usa, Llc. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
21
Total Recalls
2022
First Recall
2026
Most Recent
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Jan 12, 2026
· Device
Open, Classified
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids t...
Dec 16, 2025
· Device
Open, Classified
IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site...
Dec 3, 2025
· Device
Open, Classified
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Dec 1, 2025
· Device
Open, Classified
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Oct 28, 2025
· Device
Open, Classified
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code:...
Aug 1, 2025
· Device
Open, Classified
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-...
Aug 1, 2025
· Device
Open, Classified
LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.
Aug 1, 2025
· Device
Open, Classified
LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET...
Aug 1, 2025
· Device
Open, Classified
IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15...
Jun 6, 2025
· Device
Open, Classified
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005.
Indicated for use in a hospital and in outpatient car...
Feb 4, 2025
· Device
Open, Classified
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Jan 8, 2025
· Device
Open, Classified
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump soft...
Sep 26, 2024
· Device
Open, Classified
LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-...
Sep 4, 2024
· Device
Open, Classified
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Apr 11, 2024
· Device
Open, Classified
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Mar 11, 2024
· Device
Completed
LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004
Mar 11, 2024
· Device
Completed
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004
Dec 20, 2023
· Device
Open, Classified
Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1
Part Number: LVP-SW-0004.
In...
Sep 25, 2023
· Device
Open, Classified
Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004
Apr 18, 2023
· Device
Open, Classified
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004
version 5.2.0
Oct 6, 2022
· Device
Terminated