Manufacturer
95 recalls in our database name Fresenius Kabi USA, LLC as the manufacturing or recalling firm.
Of the 95 recalls from Fresenius Kabi USA, LLC we have scored against our rubric, 8 (8%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 34 (36%) are Severe.
Which agencies issued them
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Fresenius Kabi is recalling 30 units of Ivenix Infusion System LVP software to emphasize the instructions for LVP duration programming set out in the IFU.
Fresenius Kabi USA is recalling Ivenix Infusion System LVP software versions 5.10.1 and earlier, which the firm states contain anomalies with the potential to cause serious patient harm or death.
Fresenius Kabi USA is recalling 483 cases of Ivenix LVP Primary Administration Sets after incorrect assembly of a specific lot that the firm states could result in serious patient injury.
Fresenius Kabi USA is recalling 15,862 Ivenix Infusion System large volume pumps because downstream occlusion alarms may occur at low flow rates when a check valve is added to the administration set.
Fresenius Kabi is recalling 2,199,850 vials of Famotidine Injection USP after out of limit results were obtained for endotoxin testing. The FDA classified it Class I.
Fresenius Kabi is recalling six Ivenix Infusion System large volume pumps over a potential issue causing the device to register phantom touches in the lower-left corner of the touchscreen.
LVP Primary Administration Sets, Single Outlet Low Sorbing, are being recalled because of the potential for external cassette leaks. 35,925 units are affected.
LVP Blood Products Administration Sets are being recalled because of the potential for external cassette leaks. 14,280 units are affected.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site, are being recalled because of the potential for external cassette leaks. 348,150 units are affected.
LVP Primary Administration Sets, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site, are being recalled because of the potential for external cassette leaks. 19,225 units are affected.
Fresenius Kabi USA is recalling IVENIX INFUSION SYSTEM LVP Blood Products Administration Sets due to a mis-assembly error that may prevent the drip chamber filter from properly filtering large blood particulates.
The FDA recalled Ivenix Infusion System software versions 5.9.2 and earlier for potential device malfunctions that could affect medication delivery. Two known anomalies may cause pump failure or improper infusion rates.
Fresenius Kabi is recalling 1,520 Ivenix infusion pumps (model LVP-0004) due to potential pneumatic valve failure that may stop active infusions or prevent pump operation. Affected units were distributed to healthcare facilities in six U.S. states.
Fresenius Kabi is recalling Ivenix Infusion System software (Version 5.9.1 and prior) due to anomalies that can cause pump malfunctions, alarms, or unresponsive screens while delivering medication, risking serious patient harm.
Fresenius Kabi is recalling LVP Primary Administration Sets due to a defect that may cause uncontrolled medication flow and potential overdose. The recall affects 4,500 pieces distributed in Colorado, Idaho, New Jersey, and Utah.
Fresenius Kabi USA is recalling Ivenix Infusion System software version 5.8.0 for anomalies that could cause incorrect medication dosing or therapy delays. The Class I recall affects 17 units across 13 US states.
Fresenius Kabi recalls Ivenix Infusion System software versions 5.2.1 and 5.2.2 due to two defects that may delay therapy or cause over-infusion. The software fix was deployed to affected units between May and August 2023.
Fresenius Kabi is recalling software versions 5.0.1 and earlier of the Ivenix Infusion System due to a software defect that may cause an incorrect pump alarm, potentially delaying therapy. The defect was resolved in software version 5.2.1, released in September 2022.
Ivenix infusion pump may experience mechanical interference on fluid valve pins, interrupting therapy delivery. FDA recalled 938 units in five states due to potential risk of serious patient harm.
Fresenius Kabi USA has recalled Ivenix Infusion System Large Volume Pump software versions 5.0.0 and 5.0.1 due to startup time delays that may exceed 6 minutes at flow rates between 50-200 ml/hr.
Fresenius Kabi is recalling the Ivenix Infusion System Large Volume Pump (Model LVP-0004) because fluid ingress can damage the device, causing loss of electrical function and preventing or halting infusion.
Fresenius Kabi is recalling Sensorcaine anesthetic injections nationwide due to subpotent epinephrine content. Affected batches may not provide adequate anesthesia or hemostasis during procedures.
Sensorcaine injectable anesthetic is being recalled because testing showed the epinephrine component is below the required potency level. No illnesses or injuries have been reported.
Fresenius Kabi is recalling Sensorcaine-MPF local anesthetic vials due to subpotent epinephrine levels. The affected batch (31,600 vials) was distributed nationwide.
Fresenius Kabi is recalling the Ivenix Infusion System (IIS) LVP Software version 5.2.0 because the display screen may freeze and become unresponsive, stopping medication flow and requiring immediate clinician intervention.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
Fresenius Kabi
company based in Bad Homborg, Germany; offers health products for the critically and chronically ill.
Source: Wikidata (Q1455670), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.