Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ivenix Infusion System (IIS) Recalled by Fresenius Kabi USA, LLC Due to Potential issue that can cause the device to...

Date: September 3, 2025
Company: Fresenius Kabi USA, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.

Affected Products

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Quantity: 6 units

Why Was This Recalled?

Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report