Fresenius Kabi urges removal of dropped Ivenix infusion pumps after safety correction

Fresenius Kabi has issued a safety notice for its Ivenix large-volume infusion pumps. The FDA classified the issue as a Class I recall, the most serious level, because the touchscreen can become unresponsive after a drop or severe jarring, potentially leading to serious injury or death.

Customers were told to stop using any pump that has been dropped or jarred, even if no damage is visible, and to have the device corrected before further use. The company sent a letter on April 30 with instructions to contact its support line for guidance.

The notice is separate from earlier communications in February and July 2026 that addressed software and other hardware corrections for the same pump line. Users should also follow the "Proper Handling of the Ivenix Large Volume Pump" safety tip sheet provided by Fresenius Kabi.