ICU Medical, Inc. recalls Plum Duo Infusion System, List Number 40002-04-01
- Recall date
- December 15, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1094-2026
- FDA classification
- Class II
- Brand / firm
- ICU Medical, Inc.
- Sold / distributed
- Worldwide - US Nationwide distribution.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Plum Duo Infusion System, List Number 40002-04-01
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