Class II recallOngoing

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), recall — FDA event 98128

FDA · FDA event 98128 · Posted Jan 16, 2026

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

Update delayed: We have not successfully checked this official source since 2026-10-08 18:58:41 UTC. This page may not include the latest recall or safety information. Check the linked FDA source before making a health decision.

What happened

Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.

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

ICU Medical issued an URGENT MEDICAL DEVICE CORRECTION notice to its consignees on 12/15/2025 via mail, email, telephone, or hand delivery. The notice explained the issue, potential risk and requested the following: "Actions for Users Identify all affected infusion pumps in your possession and ensure all users or potential users of these pumps are immediately made aware of this notification and the sequence of events described. If you do experience this issue, the following mitigations can be performed: " To program the piggyback flush, the clinician must either a) clear infusion program data and power cycle the pump or b) obtain a replacement pump. " The clinician may also continue with the piggyback infusion without using the piggyback flush feature. To manually flush the downstream line, attach and program a flush syringe or bag on Line 2 to flush the fluid from the downstream line at the piggyback rate before restarting the primary line."
For device correction inquiries, contact https://icumed.custhelp.com/app/market-action. For technical support, contact: 1-(800)-241-4002, option 3; tsc.support@icumed.com. For complaints, contact: 1-844-654-7780 (M-F, 8:00 am 5:00 pm CT) or ProductComplaintsPP@icumed.com.

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

Affected products and models

This FDA record lists ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), by ICU Medical, Inc..

Products affected by FDA event 98128
Model	Description	Lot / serial range	Manufactured	Status
Z-1120-2026	Z-1120-2026	400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0	Not provided in the normalized record	Ongoing
Z-1119-2026	Z-1119-2026	400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0	Not provided in the normalized record	Ongoing
Z-1118-2026	Z-1118-2026	400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0	Not provided in the normalized record	Ongoing

Distribution: Worldwide distribution - US Nationwide and the country of Philippines.
Units affected: See official FDA record
Category: Infusion pumps

Timeline

Dec 15, 2025
Recall initiated
Date recorded by the FDA.
Jan 16, 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: 98128
Published: Jan 16, 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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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

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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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ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), recall — FDA event 98128

FDA · FDA event 98128 · Posted Jan 16, 2026

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

What happened

Affected products and models

This FDA record lists ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), by ICU Medical, Inc..

Products affected by FDA event 98128
Model	Description	Lot / serial range	Manufactured	Status
Z-1120-2026	Z-1120-2026	400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0	Not provided in the normalized record	Ongoing
Z-1119-2026	Z-1119-2026	400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0	Not provided in the normalized record	Ongoing
Z-1118-2026	Z-1118-2026	400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0	Not provided in the normalized record	Ongoing

Distribution

Worldwide distribution - US Nationwide and the country of Philippines.

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

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), recall — FDA event 98128

Follow ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US),

What happened

Who may be affected

What the official notice recommends

Affected products and models

Timeline

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), recall — FDA event 98128

Follow ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US),

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