Fresenius Kabi USA, LLC medical device recall: Ivenix Infusion System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98009
- Recall initiated
- Nov 14, 2025
- Classified by FDA
- Dec 16, 2025
- Posted in Enforcement Report
- Dec 24, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- North Andover, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Products in this event
- 1
What to do
Compare the product, lot or serial numbers below with what you have. If you use a prescription drug or medical device in this recall, talk to your pharmacist or health care provider before you stop using it, and follow the firm's instructions.
Reason for recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
What the classification means
- Class I: FDA's most serious category: there is a reasonable probability that using or being exposed to the product will cause serious health problems or death.
About this recall
The firm started this recall on Nov 14, 2025. FDA classified it 32 days later, on Dec 16, 2025. Distribution reported by FDA: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI. Fresenius Kabi USA, LLC has 67 recalls in our records.
Recalled products (1)
Z-0885-2026 Class I Ongoing
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Codes / lots: Software Versions 5.10.1 and prior; UDI: 00811505030122.
Quantity: 30 units
Source and freshness
- Source
- U.S. Food and Drug Administration (FDA) Enforcement Report, via the openFDA device enforcement dataset
- Official notice
- FDA Enforcement Report, event 98009
- Raw record
- openFDA API (JSON)
- Dataset last updated by FDA
- Nov 3, 2026
- Imported by RecallRadar
- Nov 4, 2026
Enforcement Report entries describe recalls FDA has classified. They are not always the same as a company press release. If something here differs from FDA's record, FDA's record is correct — please tell us.