Baxter Healthcare recall: Baxter Novum IQ Syringe Pump
Baxter Healthcare Corporation is recalling Baxter Novum IQ Syringe Pump – 14601 units; 4 units. The U.S. Food and Drug Administration published the recall on September 9, 2026; it began on August 11, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Baxter Novum IQ Syringe Pump |
| Brand | Baxter Healthcare |
| Company | Baxter Healthcare Corporation |
| Type | Medical devices |
| Classification | Class II |
| Recall date | August 11, 2026 |
| Published by FDA | September 9, 2026 |
| Quantity | 14601 units; 4 units |
| Recall ID | 99557 |
Recalled products (2)
- Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS
- FDA recall number
- Z-3065-2026
- Codes, lots and dates
- UDI-DI 05413765852428, all serial numbers
- Quantity
- 14601 units
- Classification
- Class II
- Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL
- FDA recall number
- Z-3066-2026
- Codes, lots and dates
- UDI-DI 00197886002300, all serial numbers
- Quantity
- 4 units
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99557
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Deerfield, IL, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “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.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99557, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other Baxter Healthcare recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Sep 30, 2026 |  Baxter Healthcare recall: Volara, HC, Na aMedical devices · 2 | Contamination within the release test equipment flow path could have affected the accuracy… Serious | FDA Class II |
| Sep 30, 2026 | Baxter Healthcare recall: Pro+ MRS Surface for Versacare and 2 more productsMedical devices · 169 units; 824 units; 6 units | There is an error in the product description on the Unique Device Identification (UDI) lab… Serious | FDA Class II |
| Sep 16, 2026 |  Baxter Healthcare recall: Dextrose InjectionDrugs · 606 bags | Presence of Particulate Matter: particulate matter identified as stainless steel particles… Most serious | FDA Class I |
| Sep 9, 2026 | Baxter Healthcare recall: 0.9% Sodium Chloride Injection USPDrugs · 145,464 500mL bags | Presence of particulate matter: Particulates identified as fiberglass Most serious | FDA Class I |
| Sep 9, 2026 | Baxter Healthcare recall: Vancomycin Injection and 10 more productsDrugs · N/A | manufacturing-practice violations Serious | FDA Class II |
| Aug 19, 2026 | Baxter Healthcare recall: Baxter Duo-Vent Solution Set and Male Luer Lock AdapterMedical devices · 24528 units | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pres… Most serious | FDA Class I |
| Aug 19, 2026 | Baxter Healthcare recall: Cefazolin in DextroseDrugs · 19,032 bags | Presence of Particulate Matter Most serious | FDA Class I |
All 8 Baxter Healthcare recalls →
About this recall
Is Baxter Healthcare Baxter Novum IQ Syringe Pump recalled?
Yes. Baxter Healthcare Corporation recalled it on August 11, 2026; FDA published it September 9, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
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 should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.