Fresenius Kabi Ivenix Infusion Pump Recall: Phantom Touches on Screen

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Contact the company & request your remedy

Recalling firmFresenius Kabi USA, LLC50 High St Ste 50, N/A · North Andover, MA 01845-2620

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Fresenius Kabi is recalling its Ivenix Infusion System Large Volume Pump (model LVP-0004) because it may register phantom touches on the touchscreen. This could cause unintended actions during use, but it does not pose a risk of injury or malfunction.

Why it’s dangerous

The device may register "phantom" touches in the lower-left corner of the touchscreen during operation. This could lead to unintended actions on the screen, but it does not cause injury or malfunction.

Who’s affected

Patients using the Ivenix Infusion System Large Volume Pump (model LVP-0004) with specific serial numbers are affected. Healthcare providers and patients using this device are most at risk.

How to tell if you have this one

Check for model number LVP-0004 on the device. Affected units have specific serial numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.

Brand
Fresenius Kabi
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Device Model
Look for model number LVP-0004 on the device label.

✎ GovInfoNow

Questions people ask

Is this recall dangerous?

No, the recall is for a potential phantom touch issue that does not cause injury or malfunction.

What should I do if I have this device?

Check the device model and serial numbers to see if it is affected. The remedy is not specified in this recall notice.

How can I tell if my device is affected?

Affected units have model number LVP-0004 and specific serial numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.

Take action

Contact Fresenius Kabi

We’ve drafted a message you can send Fresenius Kabi to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-0378-2026 — Fresenius Kabi Fresenius Kabi

Hello,

I own a Fresenius Kabi that is covered by recall Z-0378-2026 from Fresenius Kabi.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-0378-2026 (September 3, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0378-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.

Lower-risk recall