FDA recall, , Moderate risk
ICU Medical Plum Duo Infusion System
The Plum Duo Infusion System may fail to produce audible alarms, alerts, or feedback for touchscreen inputs.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical, Inc. of Lake Forest, Illinois is recalling the Plum Duo Infusion System because the company received one lot of defective primary speakers from a supplier that may fail to produce an audible sound. If the primary speaker in the pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
The recall involves 423 units distributed nationwide in the US. ICU Medical began the recall on December 15, 2025, and the FDA added it to the Enforcement Report on January 15, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
Plum Duo Infusion System, List Number 40002-04-01
- UDI-DI
- 50000221
- 50000294
- 50000295
- 50000296
- 50000298
- 50000299
- 50000300
- 50000303
- 50000304
- 50000309
- 50001663
- 50001664
- 50001665
- 50001666
- 50001667
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- 50001669
- 50001670
- 50001671
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- 50003806
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- 50003809
- 50003810
- 50004066
- 50004274
- 50004364
- 50001764
- 50001830
Recall details
- Company began the recall
- Sold in
Worldwide - US Nationwide distribution.
- Company
- ICU Medical, Inc.Lake Forest, Illinois
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98129
- Recall number
- Z-1094-2026
- Quantity recalled
- 423 units
All recalls from ICU Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
