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Class IIOngoing

Baxter Healthcare Corporation recalls 2 products

Recall date · record updated Sep 9, 2026 · Source: U.S. Food and Drug Administration (openFDA device enforcement)

What to do

Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.

Company
Baxter Healthcare Corporation
Reason
A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be Infused (VTBI) remains.
Hazard
FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).
Who’s affected
US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV.
Where
Nationwide
Official notice
www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99557…

Products (2)

  1. Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

    Codes/lots: UDI-DI 05413765852428, all serial numbersQuantity: 14601 unitsRecall no. Z-3065-2026Class II

  2. Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

    Codes/lots: UDI-DI 00197886002300, all serial numbersQuantity: 4 unitsRecall no. Z-3066-2026Class II

Update history

  1. First listed on OVERLOOKED from the official record.

When the agency expands or changes this recall, we update this page and log the change here.

Proof: raw official record (JSON) · fetched from FDA API

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