Class II recallOngoing

Infusion Pump recall — FDA event 98306

FDA · FDA event 98306 · Posted Feb 13, 2026

Published Feb 13, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

Pumps were released without full testing being performed, including occlusion alarm testing.

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

Firm notified the single customer on 1/13/26 via phone call. Customer was asked to work with on-site service technician to coordinate return of affected product.

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

Affected products and models

This FDA record lists Infusion Pump by Baxter Healthcare Corporation.

Products affected by FDA event 98306
Model	Description	Lot / serial range	Manufactured	Status
Z-1368-2026 · 3570009 · N/A	Infusion Pump	Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599	Not provided in the normalized record	Ongoing

Distribution: States: Ohio Countries: United States
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Jan 13, 2026
Recall initiated
Date recorded by the FDA.
Feb 13, 2026
Posted by FDA
The recall event appeared in the FDA source.
Oct 8, 2026
Last checked
MedWatcher last reconciled this record with the openFDA export.

Primary source

U.S. Food and Drug Administration

Identifier: 98306
Published: Feb 13, 2026
Source checked: 2026-10-08 16:03:16 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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Infusion Pump recall — FDA event 98306

FDA · FDA event 98306 · Posted Feb 13, 2026

Published Feb 13, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

Products affected by FDA event 98306
Model	Description	Lot / serial range	Manufactured	Status
Z-1368-2026 · 3570009 · N/A	Infusion Pump	Lot Code: GTIN 00085412610900, Serial Numbers 3815663, 3823468, 3824743, 3825234, and 3825599	Not provided in the normalized record	Ongoing

Distribution

States: Ohio Countries: United States

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

Infusion Pump recall — FDA event 98306

Follow Infusion Pump

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

Infusion Pump recall — FDA event 98306

Follow Infusion Pump

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