Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1120-2026·Announced 2026-01-28

Plum Solo pumps recalled over hard limit messages blocking flush programming

ICU Medical is recalling the Plum Solo Precision IV Pump because clinicians may receive an Upper or Lower Hard Limit violation message that prevents a piggyback flush from being programmed.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record's stated consequence is that a flush cannot be programmed, with no patient harm or reported injury.

Plain-English summary

The ICU Medical Plum Solo Precision IV Pump, list numbers 400010401 (US) on software version 1.0.2 and 400011001 (Philippines) on software version 1.0.0, is being recalled by ICU Medical, Inc.

The record states that Plum Solo and Duo infusion pumps include a feature that, when selected, automatically flushes the downstream line after a piggyback therapy, with the programmed flush volume delivered from the primary line container at the piggyback therapy rate once the piggyback therapy is complete. The record states that in certain cases 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.

The record does not state a quantity. Distribution was worldwide, covering the United States nationwide and the Philippines. The FDA has classified the action as Class II.

The stated consequence in the enforcement record is that the flush cannot be programmed, and no injuries are reported. Facilities should follow ICU Medical's instructions.

The recalled product

Product: ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Infusion pump
Hazard: software-fault
hard-limit-alert
piggyback-flush

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 (4)

400010401 (US)
Software Versions: 1.0.2
400011001 (Philippines)
Software Versions: 1.0.0

Distribution

Distributed nationwide across the United States.

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.

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Same hazard · software fault