Ivenix Infusion System recallZ-2224-2026 · Fresenius Kabi USA, LLC · initiated May 6, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
FDA root cause category: Device Design
What the company is doing
On May 6, 2026 URGENT - Medical Device Field Correction letters were sent to customers. Required Actions for Healthcare Providers 1. If a unit has been dropped or severely jarred, remove it from service, even if no damage is visible. 2. Once you have removed the pump from service, or if you have questions about whether to do so after a drop, please contact Fresenius Kabi customer support at [email protected] or (855) 354-6387. 3. Post enclosed Safety Tip Sheet, Proper Handling of the Ivenix Large Volume Pump (LVP) notice within your facilities to ensure that all ancillary staff are informed of this notification and trained on the action to remove any dropped or severely jarred devices from use. 4. Notify other users if applicable. If your facility distributes or transfers devices to other locations, notify all anticipated users of this correction.
Recall details
- Recall number
- Z-2224-2026
- Status
- Open, Classified
- Initiated by the company
- May 6, 2026
- Posted by the FDA
- May 29, 2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 18,444
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
Product description
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Code information (models, lots, serial numbers)
Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix Infusion System LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
Product lines
Other devices under the same FDA submission
3 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Ivenix Infusion System 030-0028-08Fresenius Kabi AG · Pump, Infusion7 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
- Ivenix Infusion System 030-0028-07Fresenius Kabi AG · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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