Class II recallOngoing

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

FDA · FDA event 98872 · Posted Jun 5, 2026

Published Jun 5, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

What happened

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.

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 April 29, 2026, the firm notified consignees via letters titled "URGEND MEDICAL DEVICE CORRECTION."
Customers were instructed to identify all affected pumps in their possession and ensure all users or potential users of the pumps are immediately made aware of the notification.
During bolus programming, clinicians should check whether the soft limit override icon is displayed next to the bolus dose entry field on the programming screen. If the pump displays the icon, the clinician should review the program and make any necessary adjustments before confirming the program.
The firm is developing a software update to correct the issue and will notify customers when it is available.

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

Affected products and models

This FDA record lists Plum Duo Infusion Pump, 40002-0401 by ICU Medical, Inc..

Products affected by FDA event 98872
Model	Description	Lot / serial range	Manufactured	Status
Z-2313-2026	Z-2313-2026	UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3	Not provided in the normalized record	Ongoing
Z-2312-2026	Z-2312-2026	UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3	Not provided in the normalized record	Ongoing
Z-2311-2026	Z-2311-2026	UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3	Not provided in the normalized record	Ongoing

Distribution: Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Apr 29, 2026
Recall initiated
Date recorded by the FDA.
Jun 5, 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: 98872
Published: Jun 5, 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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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 I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.

FDA · FDA event 98929Posted Jun 3, 2026

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

FDA · FDA event 98872 · Posted Jun 5, 2026

Published Jun 5, 2026Updated Oct 8, 2026Source last checked: 2026-10-08 16:03:16 UTC

Affected products and models

This FDA record lists Plum Duo Infusion Pump, 40002-0401 by ICU Medical, Inc..

Products affected by FDA event 98872
Model	Description	Lot / serial range	Manufactured	Status
Z-2313-2026	Z-2313-2026	UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3	Not provided in the normalized record	Ongoing
Z-2312-2026	Z-2312-2026	UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3	Not provided in the normalized record	Ongoing
Z-2311-2026	Z-2311-2026	UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3	Not provided in the normalized record	Ongoing

Distribution

Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

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 I recallOngoing

LVP software of the Ivenix Infusion System (IIS) recall — FDA event 98929

FDA · FDA event 98929Posted Jun 3, 2026

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

Follow Plum Duo Infusion Pump, 40002-0401

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

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

Follow Plum Duo Infusion Pump, 40002-0401

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