Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS

Recall Insight

This FDA Devices action (record #Z-1767-2025) was formally reported on May 28, 2025, with the manufacturer initiating the action on April 24, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Baxter Healthcare Corporation is listed as the recalling firm, operating out of Deerfield, IL. Federal records indicate 34,524 units units are affected.

The documented reason for this recall is: There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of the "standby mode" feature or if the device is powered off with the set loaded. Distribution data in the federal record shows the product reached: US and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 1 year old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.