Baxter Healthcare Corporation recalls Baxter Novum IQ Syringe Pump

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.

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.

• FDA enforcement recordOfficial FDA database entry for Z-3065-2026
• FDA 510(k) clearance · K242390The device's official FDA premarket clearance record
• FDA device classification · FRNOfficial FDA classification for this device type
• CFR regulation · 21 CFR 880.5725The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Baxter Healthcare CorporationSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.