FDA-Device2026-07-22Class IIPROCESSING DEFECT
ICU Medical Plum Duo Infusion Pump recalled for potential overdose risk
What this means
Certain ICU Medical Plum Duo infusion pumps may fail to track the amount of fluid delivered on the screen display. In rare cases, this could cause the pump to deliver up to twice the intended volume of medication or fluid. This affects specific serial numbers of two item numbers (400020401 and 400020403) running software version 1.2.3.
- Check if your pump matches one of the affected item and serial numbers listed in the FDA notice.
- If your pump is affected, stop using it and contact ICU Medical or your hospital's clinical engineering department for instructions.
- Do not rely on the volume display to verify how much fluid has been delivered.
The agency's original wording
Hazard
In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide distribution - US Nationwide and the country of Canada.
Affected count
12525 units
Manufactured in
600 N Field Dr, Lake Forest, IL, United States
Products
ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number 400020401 and 2) Item Number 400020403; infusion pump
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2723-2026More ICU Medical recalls
- FDA-Device2026-07-22ICU Medical Plum Solo Precision IV Pump v1.0.3 recalled for potential overdose risk
- FDA-Device2026-06-17ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
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