FDA-Device2026-09-09Class IIPROCESSING DEFECT
Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
What this means
A software problem in the Baxter Novum IQ Syringe Pump (Model 40800BAXUS) can occur when a syringe empties and is replaced during a multi-syringe infusion, potentially affecting the accuracy of medication delivery. The issue affects about 14,601 units distributed nationwide.
- Check if you operate or manage this syringe pump model (40800BAXUS).
- Contact Baxter Healthcare directly for instructions on software updates or corrective actions.
- Do not discard the pump; follow Baxter's guidance for safe continued use or return.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
14601 units
Manufactured in
1 Baxter Pkwy, N/A, Deerfield, IL, United States
Products
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3065-2026More Baxter recalls
- FDA-Device2026-09-09Baxter Novum IQ Syringe Pump recalled for software issue during multi-syringe infusion
- FDA-Drug2026-09-09Baxter Clindamycin Phosphate injection recalled for manufacturing compliance deviations
- FDA-Drug2026-09-09Baxter Vancomycin Injection recalled for CGMP manufacturing deviations
- FDA-Drug2026-09-09Baxter Clindamycin Injection recalled for manufacturing quality deviations
- FDA-Drug2026-09-09Baxter Vasopressin injection recalled for manufacturing quality deviations
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