Recall Z-3065-2026 ยท FRN Pump, Infusion
Baxter Healthcare Corporation
Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
| Date | Aug 31, 2026 (initiated Aug 11, 2026) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Software design |
| 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K242390 | Novum IQ Syringe Pump (40800BAXUS) Baxter Healthcare Corporation, Sep 5, 2024 |