Fresh Recalls

FDAClass II · Medical device · Recall Z-3065-2026 · Recalled September 9, 2026

Baxter Novum IQ Syringe Pump recall — Baxter Healthcare Corporation

Agency report date: September 9, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Baxter Novum IQ Syringe Pump
Company / brand
Baxter Healthcare
Lot / serial / date codes
UDI-DI 05413765852428, all serial numbers
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.
Agency product description and boundaries

Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: 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.

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Baxter Novum IQ Syringe Pump recall status

3. Open the official notice or contact

View the official FDA enforcement record (openFDA) ↗

Official recall ID
Z-3065-2026
Brand
All Baxter Healthcare recalls
Classification
Class II
Units affected
14601 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Deerfield, IL, United States
Firm address
1 Baxter Pkwy, N/A, 60015-4625

Identifying details (verbatim from the notice)

Product codes / lots
UDI-DI 05413765852428, all serial numbers
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.
Firm notified the public via
Letter
FDA event ID
99557
Recall initiated
August 11, 2026
FDA classified
August 31, 2026
FDA report date
September 9, 2026

More Baxter Healthcare recalls

Other medical device recalls from around the same time

Verify with the official sources:

Found something wrong or missing? Report a data error.

Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved October 22, 2026 at 6:00 PM UTC.

Report a data error on this page