Fresenius Kabi USA, LLC medical device recall: LVP software of the Ivenix Infusion System
Key facts
- Agency
- U.S. Food and Drug Administration (FDA)
- Program
- Medical devices
- Classification
- Class I
- Status
- Ongoing
- Event ID
- 98929
- Recall initiated
- May 6, 2026
- Classified by FDA
- Jun 3, 2026
- Posted in Enforcement Report
- Jun 10, 2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Firm location
- North Andover, MA, United States
- Initiated by
- Voluntary: Firm initiated
- Firm notified customers by
- Letter
- 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
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
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 May 6, 2026. FDA classified it 28 days later, on Jun 3, 2026. Distribution reported by FDA: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, 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-2223-2026 Class I Ongoing
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Codes / lots: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Quantity: 32 systems
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 98929
- 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.