# FDA recall Z-2311-2026

> **ICU Medical, Inc.** · Class II · device recall initiated 2026-04-29.

## Product

Plum Solo Precision IV Pump, 40001-0401

## Reason for recall

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.

## Distribution

Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.

## Key facts

- **Recall number:** Z-2311-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2026-04-29
- **Report date:** 2026-06-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2311-2026

## Citation

> MORVS. FDA recall Z-2311-2026. Retrieved 2026-10-17 from https://api.morvs.ai/recall/Z-2311-2026. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*