Ivenix, Inc. recallZ-0885-2026 · Fresenius Kabi USA, LLC · initiated Nov 14, 2025
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
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
FDA root cause category: Software design
What the company is doing
Consignees were emailed an "URGENT - Medical Device Field Correction" notice dated 11/14/25. The notice instructs consignees to review and become familiar with the provided notification's risk mitigation actions; the notice is to be forwarded if affected units were further distributed and users are to be notified. Consignees are to facilitate the installation of the new Ivenix Infusion Management System (version 5.2.2) and Large Volume Pump (5.10.2) software versions utilizing the provided instructions. Consignees are to note that the LVP will not be available for use during the update. Completed Customer Reply Forms may be sent via email to [email protected]. Customer questions can be directed to Customer Support via email at [email protected] or by phone at 1-855-354-6387.
Recall details
- Recall number
- Z-0885-2026
- Status
- Open, Classified
- Initiated by the company
- Nov 14, 2025
- Posted by the FDA
- Dec 16, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 30 units
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Product description
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Code information (models, lots, serial numbers)
Software Versions 5.10.1 and prior; UDI: 00811505030122.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix, Inc. 2.0Fresenius Kabi AG · Pump, Infusion10 recalls0 reports
Product lines
Other devices under the same FDA submission
4 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 LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
- 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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