PlainRecordsBaxter Novum IQ Syringe Pump…
- Reason
- Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete…
- Status
- Ongoing
- Distribution
- US Nationwide distribution.
- Enforcement report date
- June 18, 2025
- Risk class
- Class II (FDA's definition, 21 CFR 7.3(m): a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote)
- Status
- Ongoing (FDA's definition: a recall which is currently in progress; as in openFDA's data of Nov. 10, 2026)
- Filed by
- Baxter Healthcare Corporation
- Product
- Baxter Novum IQ Syringe Pump, product code 40800BAXUS,
- Reason
- Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.
- Distribution pattern
- US Nationwide distribution.
- Quantity
- 8027 units
- Codes and lots
- UDI/DI 05413765852428, All Serial Numbers
- Recall started
- May 12, 2025
- Voluntary or mandated
- Voluntary: Firm initiated
- Device type
- Pump, Infusion
- Root cause (FDA)
- Device Design
- What the company told customers
- Baxter issued an URGENT MEDICAL DEVICE RECALL notice to is consignees on 05/12/2025 via USPS First Class Mail. The notice explained the issue, risk, and requested the following: Actions to be Taken by Customers 1. Customers may continue to use the Novum IQ syringe pump until the pumps can be repaired. If the pump detects a syringe when no syringe is present, or you experience System Error 21502 (Flange Sensor Failure), power cycle the device and reload the syringe. Complete the therapy and remove the pump from service. 2. A Baxter representative will contact your facility to coordinate the repair of your Novum IQ syringe pumps. Please note you will be receiving this repair from Baxter at no charge. 3. Acknowledge receipt of this notification by following the instructions on the enclosed reply instruction sheet, even if you have no remaining inventory. Acknowledging receipt will prevent you from receiving repeat notices. If you do not complete the acknowledgement, you will receive a phone call from OnProcess Technology on behalf of Baxter to confirm your receipt of this notification. 4. Please forward a copy of this communication to the Chief Medical Officer, Medical Director, Director of Nursing, Director of Pharmacy, Facility Risk Manager, Director of Purchasing/Central Supply, and any other departments within your institution who use the affected product. For general questions regarding this communication, or if you experience quality problems, please contact your Baxter sales representative, or Baxter Global Technical Services at 800-843-7867, Monday through Friday, between 7:00 am and 7:00 pm Eastern Time.
- Recall number
- Z-1964-2025
What this record is about
A generic icon of the kind of thing the record is about; the record's own words are below. It is not a picture of the product.
“Baxter has identified a design issue which may cause the pump to detect the presence of a syringe flange when no syringe is loaded. When this issue occurs, the pumps 'user interface becomes stuck on the "Remove Syringe" screen when an infusion is complete, and the syringe is unloaded. A System Error 21502 (Flange Sensor Failure) may occur. Please note this issue only affects a subset of Novum IQ syringe pumps manufactured or repaired after July 4, 2023.”Baxter Novum IQ Syringe Pump, product code 40800BAXUS,, FDA enforcement report, 2025-06-18. The caption is the record's own words.
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FDA device name: Pump, Infusion
This recall among the others
- FDA's enforcement report came 37 days after the firm started the recall. For half of the 972 FDA medical device recall events reported in 2025 with a start date, it took 44 days or fewer (by year).
- Baxter Healthcare: 83 other recalls or notices on this site in the three years before this one (from June 19, 2022).
Counted from the agency records on this site, as on Statistics: a recall event once, by its first notice.
What should I do? How serious is a recall? Classes and warnings explained · How to read this record
Source: FDA · Medical device enforcement report, recall number Z-1964-2025. See this record in openFDA (FDA's own data service; it answers in JSON). The agency record governs; check it and the company before acting.
Cite this record
FDA recall record Z-1964-2025, June 18, 2025. "Baxter Novum IQ Syringe Pump." PlainRecords, https://plainrecords.com/recall/device/z-1964-2025/ (as of the day it was built).At each build a sample of records from each source is compared with the agency's published file and the page; every correction is public. Drawings are chosen by software that reads the record. Built daily. How we check · Corrections