- Recalling firm
- Fresenius Kabi USA, LLC
- 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.
- Affected products (lot / model / serial)
- Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
- Units affected
- 32 systems
- Distribution pattern
- 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.
- Firm location
- North Andover, MA, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2223-2026
- Recall initiated
- May 6, 2026
- FDA classification date
- June 3, 2026
- FDA report date
- June 10, 2026
- FDA event ID
- 98929
- Last updated on HTM Vibe
- July 23, 2026