Fresenius Kabi USA, LLC

24 FDA enforcement actions

24 Total Recalls

10 Class I

14 Class II

0 Class III

Firm Details

Product Types: device, drug
States: MA, IL

All Recalls

Class II: Risk 11/21/2025 device

Emphasizing instructions for LVP duration programming located in the IFU.
Class I: Dangerous 11/14/2025 device

Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Class I: Dangerous 11/06/2025 drug

Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Class II: Risk 11/03/2025 device

Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Class I: Dangerous 11/03/2025 device

Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.
Class II: Risk 09/03/2025 device

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Class II: Risk 06/24/2025 device

Potential for external cassette leaks
Class II: Risk 06/24/2025 device

Potential for external cassette leaks
Class II: Risk 06/24/2025 device

Potential for external cassette leaks
Class II: Risk 06/24/2025 device

Potential for external cassette leaks
Class I: Dangerous 05/12/2025 device

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.
Class I: Dangerous 01/10/2025 device

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. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
Class I: Dangerous 12/06/2024 device

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.
Class I: Dangerous 08/30/2024 device

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.
Class I: Dangerous 08/01/2024 device

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).
Class II: Risk 11/22/2022 drug

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II: Risk 11/22/2022 drug

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class II: Risk 11/22/2022 drug

Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
Class I: Dangerous 03/04/2022 drug

Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Class II: Risk 09/17/2021 drug

Defective container: Cracked vials leading to lack of sterility assurance
Class II: Risk 06/25/2021 drug

Low out of specification results for epinephrine assay.
Class I: Dangerous 12/23/2020 drug

Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II: Risk 12/17/2020 drug

Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II: Risk 12/10/2020 drug

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.