FDAFDA recall Z-3066-2026 · Sep 9, 2026
Baxter Healthcare Corporation: Baxter Novum IQ Syringe Pump recall
Recall found
Product
Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- UDI-DI 00197886002300, all serial numbers
- Quantity
- 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.
- Recalling firm
- Baxter Healthcare Corporation, Deerfield, IL
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-08-11
Source: openFDA enforcement record Z-3066-2026 · search recall number Z-3066-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.