The Food and Drug Administration classifies the recall as the most serious type after reports of touchscreen malfunctions caused by dropped or jarred devices.
Fresenius Kabi is issuing a correction for its Ivenix Large Volume Infusion Pumps that have been dropped or severely jarred. The Food and Drug Administration has identified this as a Class I recall, the most serious type, as continued use of affected devices could cause serious injury or death.
This correction is separate from previous communications issued in February 2026 and July 2026 regarding the same devices.
The correction stems from reports that the pump touchscreen may display unintended behaviors, such as random screen touches or a lack of responsiveness to user input. According to Fresenius Kabi, this behavior is typically caused by a loosened touchscreen input cable. Testing by the company confirmed the cable can become loose when units are dropped on hard surfaces or experience severe jarring, even if there is no visible external damage.
Unintended touchscreen behavior can affect a user’s ability to manage therapy, potentially leading to interruptions or delays in treatment. As of May 6, Fresenius Kabi has reported two serious injuries and no deaths associated with the issue.
Recommendations for Healthcare Facilities
Healthcare providers are advised to immediately remove any unit from service that has been dropped or jarred, regardless of visible damage. “If a unit has been dropped or severely jarred, remove it from service, even if no damage is visible,” says Fresenius Kabi in a release.
The company sent a letter to customers on April 30 recommending these actions and providing a safety tip sheet on proper handling of the devices. Fresenius Kabi plans to update the instructions for use to clarify that impacted devices must be taken out of service. Once a pump has been removed from service, or if staff have questions regarding a device after a drop, they are encouraged to contact company support.
Device Use and Context
The Ivenix Infusion System is used in hospital and outpatient settings for the controlled administration of fluids, including medications, red blood cells, platelets, and plasma, to adult, pediatric, and neonate patients.
Customers in the US with questions, quality problems, or reports of adverse reactions should contact Fresenius Kabi support directly.
