Agency classClass IIOur severity:High FDA (Devices)·Z-2313-2026·Announced 2026-06-17

Plum Duo Precision IV pumps may not display soft limit alerts

Plum Duo Precision IV Pumps are being recalled because under certain conditions the pump may not display a soft limit alert before delivery starts, potentially leading to under- or over-delivery.

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 recall with a stated risk of under- or over-delivery when a dose-limit alert is suppressed, a risk of harm with no injuries reported.

Plain-English summary

The Plum Duo Precision IV Pump, product 40002-0403, UDI-DI M335400031, software v1.2.3, from ICU Medical, Inc., is being recalled. The action covers 13,613 units.

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. According to the manufacturer, this may potentially lead to under- or over-delivery. The FDA classified the action as Class II.

Distribution was worldwide, including within the United States in Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, New Mexico, New York, Pennsylvania, Tennessee and Texas. The pumps are used in healthcare facilities rather than sold to consumers.

Facilities should identify affected pumps using the product number, UDI-DI and software version above and follow the instructions issued by ICU Medical.

The recalled product

Product: Plum Duo Precision IV Pump, 40002-0403
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion pump
Hazard: software-anomaly
missing-alert
dose-limit
infusion-delivery
class-ii
Affected units: 13,613

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 (1)

UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3

Distribution

Distributed nationwide across the United States.

The notice also names 11 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · ICU Medical, Inc.

See all →

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Same hazard · software anomaly