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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Novum IQ

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 Class 2 Device Recall Baxter Novum IQsee related information
Date Initiated by FirmAugust 11, 2026
Date PostedAugust 31, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3065-2026
Recall Event ID 99557
510(K)NumberK242390 
Product Classification Pump, infusion - Product Code FRN
ProductBaxter Novum IQ Syringe Pump, Model Number 40800BAXUS
Code Information UDI-DI 05413765852428, all serial numbers
FEI Number 1417572
Recalling Firm/
Manufacturer		 Baxter Healthcare Corporation
1 Baxter Pkwy
Deerfield IL 60015-4625
For Additional Information ContactCenter for One Baxter
1-847-9484770
Manufacturer 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.
FDA Determined
Cause 2		Software design
ActionOn August 11, 2026, firm began sending customers Urgent Medical Device Correction delivered via email and USPS first class mail. Customers were advised to use the same compatible syringe model (brand/size) for all syringes required within a Multi-Syringe VOT workflow. Customers were provided with additional instructions for situations where the syringe does not support the intended flow rate and the user receives a prompt to confirm continuation of the infusion at the maximum or minimum supported flow rate for that syringe after a syringe change.
Quantity in Commerce14601 units
DistributionUS 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
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