Z-3066-2026Class II

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

Name: Z-3066-2026 Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Creator: Baxter Healthcare Corporation
Published: 2026-08-11
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2026-08-11 / Open, Classified / root cause: software

FDA source

Baxter Healthcare Corporation began a recall of Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL on 2026-08-11. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-3066-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-08-11
Posted: 2026-08-31
Recalling firm: Baxter Healthcare Corporation
Product: Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Product code: FRN Pump, Infusion
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.
Root cause tag: software
FDA 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 in commerce: 4 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.
Product codes and lots: UDI-DI 00197886002300, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3066-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3065-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31
Z-3066-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-09-09	2026-08-31

Product code FRN

K242390Class IINovum IQ Syringe Pump (40800BAXUS)Baxter Healthcare Corporation / cleared 2024-09-05

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)