Ivenix Infusion System — Class I medical device recall Z-2224-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-06-10, distributed in CA, CO, FL, GA, ID, IL, MD, MI…. Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP m
| Recall number | Z-2224-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2026-05-06 |
| Classified | 2026-05-29 |
| Reported by FDA | 2026-06-10 |
| Distributed | CA, CO, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI |
| Quantity | 18,444 |
| UPC / GTIN / UDI-DI | 00811505030320 |
| Model numbers | LVP-0004 |
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Reason for recall
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2224-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.