Ivenix Infusion System recallZ-2274-2026 · Fresenius Kabi USA, LLC · initiated Feb 4, 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
Potential for the Cassette Loading Lever to break.
FDA root cause category: Device Design
What the company is doing
Fresenius Kabi notified consignees on about 02/04/2026 via letter. Consignees were informed of the lever breakage and that two potential sources of the breakage were: 1. If the Cassette Loading Lever is left open during transport, it can be damaged if it is jarred by another object or surface. 2. Applying force to a locked Loading Lever when it is in the locked position can result in potential damage and/or cause it to break. Consignees were reminded of proper Loading Lever handling: 1. Do not force the Cassette Loading Lever open or closed. The lever does not require significant force to operate, and excessive force can damage the LVP. Excessive force can damage the LVP and prevent use. 2. The Cassette Loading Lever does not require excessive force to load or unload the administration set. 3. If the Cassette Loading Lever does not move with minimal force, do not continue to apply force. Check that the pump is not currently infusing and verify there are no obstructions. 4. When an infusion completes or is paused, the flow dial may take up to 5 seconds to close and unlock the Cassette Loading Lever. Consignees were also reminded of proper transport and storage to ensure the Cassette Loading Lever is fully closed prior to moving, transporting, or storing the pump, and after transport, visually confirm the Cassette Loading Lever is intact and moves freely before clinical use. Additionally, consignees were requested to complete and return the Customer Reply Form provided.
Recall details
- Recall number
- Z-2274-2026
- Status
- Open, Classified
- Initiated by the company
- Feb 4, 2026
- Posted by the FDA
- May 29, 2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 18,444 installed bases
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Product description
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Code information (models, lots, serial numbers)
Model Number: LVP-0004. UDI-DI: 00811505030320
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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