# FDA recall Z-1094-2026

> **ICU Medical, Inc.** · Class II · device recall initiated 2025-12-15.

## Product

Plum Duo Infusion System, List Number 40002-04-01

## Reason for recall

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

## Distribution

Worldwide - US Nationwide distribution.

## Key facts

- **Recall number:** Z-1094-2026
- **Recalling firm:** ICU Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-15
- **Report date:** 2026-01-21

- **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-1094-2026

## Citation

> AI Analytics. FDA recall Z-1094-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1094-2026. Source: US FDA. Licensed CC0.

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