FDA Medical Device · Z-3065-2026

Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

Class II · Ongoing

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.

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Affected lots / codes — check yours against thisUDI-DI 05413765852428, all serial numbers
Recalling firm
Baxter Healthcare Corporation, Deerfield, IL
Classification
Class II (temporary or reversible harm possible)
Status
Ongoing
Quantity
14601 units
Distribution
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.
Recall initiated
August 11, 2026
Classified
August 31, 2026
Initiation
Voluntary: Firm initiated
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Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-3065-2026%22
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Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.
Check this brand across all 8 databases →