FDA recall, , Moderate risk
Baxter Novum IQ Syringe Pump
The syringe pump has a software issue that may occur during multi-syringe infusion.
Summary by Recall Canary from the FDA notice
What happened
Baxter Healthcare Corporation of Deerfield, Illinois, recalled the Baxter Novum IQ Syringe Pump and the Baxter Novum IQ Syringe Pump, Loaner, after the FDA identified 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.
The recall began August 11, 2026, and was added to the FDA's Enforcement Report on August 31, 2026. The products were distributed nationwide across 45 states, including Alaska, Alabama, Arkansas, and others. The FDA classified the recall on August 31, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
2 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
- UDI-DI
- 00197886002300
- Lot code
- all serial numbers
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- UDI-DI
- 05413765852428
- Lot code
- all serial numbers
Recall details
- Company began the recall
- Sold in
US Nationwide distribution including in the states of Alaska, Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, and West Virginia.
- Company
- Baxter Healthcare CorporationDeerfield, Illinois
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 99557
- Recall numbers
- Z-3065-2026 to Z-3066-2026
All recalls from Baxter Healthcare Corporation
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
