FDA recall record · openFDA
Fresenius Kabi USA, LLC
37 FDA recalls on record (2023–2026) — 16 drug,21 device. 37 still ongoing.
13
Class I (most serious)
23
Class II
1
Class III
37
ongoing
How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.
Most common reasons
Lack of Assurance of Sterility 14
Potential for external cassette leaks 4
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. 1
Failed Impurities/Degradations Specifications 1
The device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The 1
Recalls
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. Class I 2026-05-06 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Class I 2026-05-06 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 Class I 2025-11-06 IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intra Class I 2025-05-12 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care enviro Class I 2025-01-10 IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Class I 2025-11-03 Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients Class I 2025-11-14 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for i Class I 2024-08-30 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Class I 2024-03-07 Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 Class I 2024-12-06 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25. f Class I 2024-08-01 Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 Class I 2023-11-29 Ivenix Infusion System (IIS), Large Volume Pump, Model No. LVP-0004 Class I 2023-03-10 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, Frese Class II 2026-03-11 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, Class II 2026-03-11 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, M Class II 2026-03-11 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, Fr Class II 2026-03-11 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, Frese Class II 2026-03-11 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 B Class II 2026-03-11 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 ("Fres Class II 2026-03-11 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 ("F Class II 2026-03-11 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 ("Fres Class II 2026-03-11 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 Class II 2026-03-11 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 ("Fres Class II 2026-03-11 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 U Class II 2026-03-11 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 B Class II 2026-03-11 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 Class II 2026-03-11 The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. Class II 2026-02-04 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032- Class II 2025-06-24 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Class II 2025-11-03 LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25. Class II 2025-06-24 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. Class II 2025-09-03 Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. Class II 2025-11-21 LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25. Class II 2025-06-24 LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20. Class II 2025-06-24 LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004 Class II 2023-05-10 Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696 Class III 2026-05-14
RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.