FDA-Device2026-01-21Class IIPROCESSING DEFECT

ICU Medical Plum Duo Infusion Pump recalled for defective speaker causing silent alarms

OTHERNationwide distribution

Check your Plum Duo Infusion Pump serial number

ICU Medical identified a batch of defective speakers in some Plum Duo Infusion Pumps that may fail silently. If the speaker fails, the pump will not produce audible alarms, alerts, or sound feedback when you touch the screen. This could delay recognition of important pump notifications.

  • Check if your Plum Duo pump's serial number is on the recall list (contact ICU Medical or your facility)
  • If your pump is affected, stop using it and contact ICU Medical or your healthcare facility immediately
  • Your facility should verify the speaker is working by testing the pump's audio alerts
  • ICU Medical will provide instructions for repair or replacement
Hazard

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.

Sold states
Worldwide - US Nationwide distribution.
Affected count
423 units
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
Plum Duo Infusion System, List Number 40002-04-01

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1094-2026

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