Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Summary
The FDA issued a Class II for Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL by Baxter Healthcare Corporation. 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 In.
Details
Source
Device Recall
External ID
Z-3066-2026
Action Date
2026-09-09
Status
Ongoing
Category
device
Product Description
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
Lot/Code Info: UDI-DI 00197886002300, all serial numbers
Quantity Affected: 4 units
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.
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-11
Company
Deerfield, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 183 device recalls issued in the same week, part of 445 device-related FDA actions this month.
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Baxter Healthcare Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Baxter Healthcare Corporation have FDA actions?
Baxter Healthcare Corporation has 335 FDA actions in our database, including 311 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3066-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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