ICU Medical, Inc.

MedWatcher tracks the reviewed device family ICU Medical Plum 360 Infusion System under the canonical manufacturer identity ICU Medical, Inc.. The recall records on this page are limited to 7 owner-approved FDA recall actions.

What MedWatcher tracks

This page covers only the reviewed device families and FDA recall actions shown below. It is not a complete product catalogue, and a recall does not necessarily affect every unit or configuration in a device family.

Reviewed device families: 1
Matched recall actions: 8
Source records last checked: Oct 8, 2026

Manufacturer identity and source matching

The manufacturer and device-family relationships come from the reviewed canonical-device inventory. Recall coverage is limited to the exact candidate IDs approved and published in the FUS-265 cohort; complete regulator payloads remain in the private source ledger.

Source databases can use a legal name, brand, division, or shortened name. MedWatcher retains the form used as evidence rather than treating every similar name as the same manufacturer.

CareFusion 303, Inc.Source-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
Fresenius Kabi USA, LLCSource-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
ICU Medical IncSource-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)
ICU Medical, Inc.Source-name variantReviewed openFDA recalling-firm identity — FUS-265Evidence source (opens in a new tab)
Smiths Medical ASD Inc.Source-name variantOwner-approved openFDA recall-match cohort (FUS-265)Evidence source (opens in a new tab)

Sources used for this page

U.S. Food and Drug AdministrationFDA medical device recall recordsLast checked Aug 16, 2026 openFDAMedical device recall bulk dataLast checked Aug 16, 2026

Page reviewed Aug 17, 2026 by fusiondesigner@gmail.com · Next review by Nov 17, 2026.

Infusion pumps

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ICU Medical Plum 360 Infusion System

ICU Medical, Inc. · Infusion pumps

Active recall record

Last checked Oct 8, 2026

Recent recall records

Class II recallOngoing

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 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

Class II recallOngoing

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

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…

FDA · FDA event 98128Posted Jan 16, 2026

Class II recallOngoing

Plum Duo Infusion System, List Number 40002-04-01 recall — FDA event 98129

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback…

FDA · FDA event 98129Posted Jan 15, 2026

Class I recallOngoing

Plum Duo Infusion System, List Number: 400020401 recall — FDA event 97186

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

FDA · FDA event 97186Posted Aug 6, 2025

Class I recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 95586

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have…

FDA · FDA event 95586Posted Nov 21, 2024ICU Medical Plum 360 Infusion System

Class I recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 94690

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

FDA · FDA event 94690Posted Aug 9, 2024ICU Medical Plum 360 Infusion System

Class II recallOngoing

ICU Medical Plum 360 Infusion System recall — FDA event 92630

Due to a manufacturing defect of a supplier provided component, there is a potential that the audible signal for an alarm may not sound under certain conditions.

FDA · FDA event 92630Posted Aug 18, 2023ICU Medical Plum 360 Infusion System

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Recent recall records

Class II recallOngoing

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 recallOngoing

Class I recallOngoing

ICU Medical, Inc.

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What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Infusion pumps

ICU Medical Plum 360 Infusion System

Recent recall records

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

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

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

Plum Duo Infusion System, List Number 40002-04-01 recall — FDA event 98129

Plum Duo Infusion System, List Number: 400020401 recall — FDA event 97186

ICU Medical Plum 360 Infusion System recall — FDA event 95586

ICU Medical Plum 360 Infusion System recall — FDA event 94690

ICU Medical Plum 360 Infusion System recall — FDA event 92630

ICU Medical, Inc.

Follow ICU Medical, Inc.

What MedWatcher tracks

Manufacturer identity and source matching

Sources used for this page

Infusion pumps

ICU Medical Plum 360 Infusion System

Recent recall records

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

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

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

Plum Duo Infusion System, List Number 40002-04-01 recall — FDA event 98129

Plum Duo Infusion System, List Number: 400020401 recall — FDA event 97186

ICU Medical Plum 360 Infusion System recall — FDA event 95586

ICU Medical Plum 360 Infusion System recall — FDA event 94690

ICU Medical Plum 360 Infusion System recall — FDA event 92630