Notice names this product. Fresenius Kabi USA’s The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) is named in FDA Class II recall Z-2274-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Potential for the Cassette Loading Lever to break. Identifying details: Model Number: LVP-0004. UDI-DI: 00811505030320. Units affected: 18,444 installed bases. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Potential for the Cassette Loading Lever to break.
Company / brand: Fresenius Kabi USA
Affected product: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS)
Official ID Z-2274-2026 · Official record ↗
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Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.