Fresenius Kabi USA, LLC recalls

30 recalls on record · latest: March 11, 2026

Official U.S. recall history for Fresenius Kabi USA, LLC, compiled from official government records.

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Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

5% Dextrose Injection recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

5% Dextrose Injection recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

5% Dextrose Injection recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA product recalled over sterility concerns

March 11, 2026 · Drug & medication recalls Moderate risk Lack of Assurance of Sterility

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.

November 21, 2025 · Medical device recalls Moderate risk Emphasizing instructions for LVP duration programming located in the IFU.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patient…

November 14, 2025 · Medical device recalls High risk Software version 5.10.1 and earlier contain anomalies that have the potential t…

Fresenius Kabi USA, LLC recalls Fresenius Kabi — Famotidine Injection, USP 20 mg per 2 mL

November 7, 2025 · Drug & medication recalls Out-of-specification endotoxin results — Potential Lack of sterility

Fresenius Kabi USA, LLC recalls Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-1…

November 6, 2025 · Drug & medication recalls High risk Microbial Contamination of Sterile Products; out of limit results obtained for…

Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25)…

November 3, 2025 · Medical device recalls High risk Incorrect assembly of specific lot of LVP Primary Administration Set that could…

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

November 3, 2025 · Medical device recalls Moderate risk Downstream Occlusion alarms may occur during procedures using low flow infusion…

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

September 3, 2025 · Medical device recalls Moderate risk Potential issue that can cause the device to register "phantom" touches in the…

Fresenius Kabi USA, LLC recalls LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20). Product Code: SET-0014-20.

June 24, 2025 · Medical device recalls Moderate risk Potential for external cassette leaks

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25). Product Code: SET-0021-25.

June 24, 2025 · Medical device recalls Moderate risk Potential for external cassette leaks

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25). Product Code: SET-0013-25.

June 24, 2025 · Medical device recalls Moderate risk Potential for external cassette leaks

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Product Code: SET-0032…

June 24, 2025 · Medical device recalls Moderate risk Potential for external cassette leaks

Fresenius Kabi USA, LLC recalls IVENIX INFUSION SYSTEM LVP Blood Products Administration Set, Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter, 15 mL. Intr…

May 12, 2025 · Medical device recalls High risk Mis-assembly error of Blood Products Administrations Sets where the 200-micron…

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environm…

January 10, 2025 · Medical device recalls High risk Large Volume Pump Software, version 5.9.2 and earlier has potential for the fol…

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

December 6, 2024 · Medical device recalls High risk Potential pneumatic valve failure that may cause the LVP to stop an active infu…

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for i…

August 30, 2024 · Medical device recalls High risk The software has anomalies that have the potential to cause alarms, nonfunction…

Fresenius Kabi USA, LLC recalls LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25), Product Code: SET-0013-25.…

August 1, 2024 · Medical device recalls High risk A defect may cause an uncontrolled medication flow condition which may result i…