Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
FDA Recall Z-3065-2026 · Posted 2026-08-31
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Recalling FirmBaxter Healthcare Corporation
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2026-08-11
Product Quantity14601 units
Reason for Recall
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.
Firm Action
On August 11, 2026, firm began sending customers Urgent Medical Device Correction delivered via email and USPS first class mail.
Customers were advised to use the same compatible syringe model (brand/size) for all syringes required within a Multi-Syringe VOT workflow.
Customers were provided with additional instructions for situations where the syringe does not support the intended flow rate and the user receives a prompt to confirm continuation of the infusion at the maximum or minimum supported flow rate for that syringe after a syringe change.
Root Cause
Software design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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