Recall Z-3065-2026
Baxter Healthcare Corporation · initiated August 11, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Codes / lots: UDI-DI 05413765852428, all serial numbers
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.
FDA-determined cause: Software design
Action taken
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.
Details
- Recall number
- Z-3065-2026
- Initiated
- August 11, 2026
- Posted by FDA
- August 31, 2026
- Product code
- FRN – Pump, Infusion
- Quantity
- 14601 units
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3066-2026 Class II | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches… | 08/11/2026Open, Classified |