The Recall Desk
Severity pendingFDA (Devices)·Z-2311-2026·Announced 2026-06-17

Plum Solo Precision IV Pump, 40001-0401

Pending LLM rewrite. Source: FDA_DEVICE Z-2311-2026.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
Plum Solo Precision IV Pump, 40001-0401
Manufacturer
ICU Medical, Inc.

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 M335400011 Plum Solo Precision IV Pump v1.0.3

Distribution

Distributed nationwide across the United States.