Agency classClass IIOur severity:High FDA (Devices)·Z-1991-2025·Announced 2025-06-25

ICU Medical Plum Solos Infusion Pump Software Safety Defect Recall

ICU Medical is recalling Plum Solos infusion pumps (Item 400011001) with software version 1.1.1 due to a workflow that may bypass the Maximum Dose Limit alert, which is designed to prevent overdose. The defect affects 214 units distributed across nine US states and the Philippines.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II medical device recall involving a risk-of-harm defect where the potential exists for patient harm through medication overdose, but no illnesses or injuries have been reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling the Plum Solos infusion pump (Item number 400011001) due to an internal testing finding that a workflow in software version 1.1.1 may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or body surface area (BSA) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.

A total of 214 units have been distributed across the US in the states of Florida, Kentucky, Virginia, Mississippi, Massachusetts, Pennsylvania, New York, California, and Iowa, as well as in the Philippines. The affected units are identified by specific serial/lot numbers beginning with 60000001 through 60000300 (with gaps in the sequence).

Patients and healthcare providers who have these pumps should contact ICU Medical immediately to discuss the appropriate action. The FDA classified this as a Class II recall.

The recalled product

Product: ICU Medical Plum Solos, Item number 400011001; infusion pump
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion Pump
Hazard: overdose-risk
software-defect
dose-limit-bypass
Affected units: 214

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

UDI/DI N/A
Serial/Lot Numbers: 60000001
60000002
60000003
60000005
60000006
60000007
60000008
60000009
60000010
60000011
60000014
60000015
60000016
60000017
60000019
60000020
60000021
60000023
60000024

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 2 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
High
ICU Medical Recalls IV Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls IV Administration Sets with Drip Chamber Specks
FDA (Devices) · 2026-09-23
Moderate
ICU Medical Recalls Oncology Sets with Potential Drip Chamber Discoloration
FDA (Devices) · 2026-09-23

Same hazard · overdose risk