Class II recallOngoing

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA event 99557

FDA · FDA event 99557 · FDA posted Aug 31, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

What happened

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.

Who may be affected

People using a product, model, software version, lot, or UDI listed in the affected-products table and official FDA record.
A mention of the device family does not mean every unit is affected. Compare the identifiers on your product with the official source.

What the official notice recommends

On 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.

The official notice takes precedence over this summary. Talk to your clinician before changing prescribed therapy.

Affected products and models

This FDA record lists Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL by Baxter Healthcare Corporation.

Products affected by FDA event 99557
Model	Description	Lot / serial range	Manufactured	Status
Z-3065-2026	Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS	UDI-DI 05413765852428, all serial numbers	Not provided in the normalized record	Ongoing
Z-3066-2026	Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL	UDI-DI 00197886002300, all serial numbers	Not provided in the normalized record	Ongoing

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.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Aug 11, 2026
Recall initiated
Date recorded by the FDA.
Aug 31, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 28, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 99557
Published: Aug 31, 2026
Source checked: 2026-10-28 03:25:03 UTC

Official openFDA device-recall record. The FDA source takes precedence over this normalized summary.

View official record

How MedWatcher checks these sources

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ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

FDA · FDA event 98872Posted Jun 5, 2026

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Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA event 99557

FDA · FDA event 99557 · FDA posted Aug 31, 2026

Published by MedWatcher Oct 28, 2026Record source last checked: 2026-10-28 03:25:03 UTC

Affected products and models

This FDA record lists Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL by Baxter Healthcare Corporation.

Products affected by FDA event 99557
Model	Description	Lot / serial range	Manufactured	Status
Z-3065-2026	Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS	UDI-DI 05413765852428, all serial numbers	Not provided in the normalized record	Ongoing
Z-3066-2026	Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL	UDI-DI 00197886002300, all serial numbers	Not provided in the normalized record	Ongoing

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.

Units affected

See official FDA record

ICU Medical Plum Duo Infusion Pump, v1 recall — FDA event 99192

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

FDA · FDA event 99192Posted Jul 10, 2026

Class II recallCompleted

Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, recall — FDA event 99063

There is the potential for leakage along the drug pathway from the pump through the end of the catheter.

FDA · FDA event 99063Posted Jun 25, 2026

Class II recallOngoing

Plum Duo Infusion Pump, 40002-0401 recall — FDA event 98872

FDA · FDA event 98872Posted Jun 5, 2026

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA event 99557

Follow Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL recall — FDA event 99557

Follow Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline

What happened

Who may be affected

What to do

What the official notice recommends

Affected products and models

Timeline