Novum IQ recallZ-3065-2026 · Baxter Healthcare Corporation · initiated Aug 11, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Baxter Healthcare Corporation or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Software design
What the company is doing
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.
Recall details
- Recall number
- Z-3065-2026
- Status
- Open, Classified
- Initiated by the company
- Aug 11, 2026
- Posted by the FDA
- Aug 31, 2026
- Recalling firm
- Baxter Healthcare Corporation
- Quantity
- 14601 units
- Product code
- FRN
- FDA submissions
- K242390
- 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.
Product description
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Code information (models, lots, serial numbers)
UDI-DI 05413765852428, all serial numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Novum IQ 40800BAXUSBaxter Healthcare Corporation · Pump, infusion4 recalls348 reports
Product lines
Other devices under the same FDA submission
1 device cleared under K242390 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Novum IQ 40800BAXUSLBaxter Healthcare Corporation · Pump, infusion, enteral1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 99557).
- Z-3066-2026 · Open, ClassifiedBaxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page