FDAClass II · Medical device · Recall Z-2274-2026 · Recalled June 10, 2026

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC

Agency report date: June 10, 2026.

1. Compare your item

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.

Product named: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS)
Company / brand: Fresenius Kabi USA
Lot / serial / date codes: Model Number: LVP-0004. UDI-DI: 00811505030320
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

Agency product description and boundaries

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.

2. Agency hazard and consumer action

FDA reports: Potential for the Cassette Loading Lever to break.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS)

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2274-2026
Brand: Fresenius Kabi USA
Classification: Class II
Units affected: 18,444 installed bases
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Affected products

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS)

Companies & origin

Recalling firm location: North Andover, MA, United States
Firm address: 50 High St Ste 50, 01845-2620

Identifying details (verbatim from the notice)

Product codes / lots: Model Number: LVP-0004. UDI-DI: 00811505030320
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Firm notified the public via: E-Mail
FDA event ID: 98699
Recall initiated: February 4, 2026
FDA classified: May 29, 2026
FDA report date: June 10, 2026

Verify with the official sources:

CPSC — consumer products ↗ (aggregated here)
NHTSA — vehicles, car seats, tires ↗ (aggregated here; use NHTSA's VIN lookup to check a specific vehicle)
FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked September 7, 2026 at 6:00 AM UTC. Record retrieved September 7, 2026 at 6:00 AM UTC.

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