Use cautionMedical device recall · FDA · Published December 15, 2025
ICU Medical recalls Plum Duo Infusion System: Possible failure to produce audible alarms
ICU Medical recalls a specific lot of Plum Duo Infusion Systems that may fail to produce audible alarms, potentially causing missed alerts during medical use. Affected units have unique serial numbers listed in the recall notice.
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.
Take action
Contact the company
📍Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835
“ICU Medical recalls Plum Duo Infusion System: Possible failure to produce audible alarms.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50451-icu-medical-recalls-plum-duo-infusion-system-possible-failure-to. Based on FDA recall #Z-1094-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1094-2026%22&limit=1).
ICU Medical, Inc. recalled Plum Duo Infusion Systems with List Number 40002-04-01 on Dec. 15, 2025, according to the FDA. The devices may fail to produce audible alarms or feedback due to defective primary speakers.
How to tell if you have it
Brand: ICU Medical
Product: Plum Duo Infusion System
List Number: 40002-04-01
UDI-DI: M335400021
Units affected: 423
The hazard
ICU Medical received one lot of defective primary speakers from its supplier that may fail to produce an audible sound. If the primary speaker fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.
Context
GovInfoNow's records show ICU Medical, Inc. has 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include the ICU Medical CADD Yellow Medication Cassette Reservoir Recall (Aug. 20, 2026), the ICU Medical Hotline Fluid Warming Set Recall (June 24, 2026), and a recall regarding pump delivery errors (June 10, 2026). Other recent recalls of similar products include Philips IntelliVue MX550 Patient Monitor Recall (Oct. 31, 2025), Philips IntelliVue MX800 Patient Monitor Recall (Oct. 31, 2025), and Philips IntelliVue MX100 Patient Monitor Recall (Oct. 31, 2025).
How to tell if you have this one
Check if your Plum Duo Infusion System has a serial number from the list provided in the recall notice. The affected units have specific serial numbers starting with 50000004 through 50000007 and others listed in the record.
Brand
ICU Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Serial Number
Verify your Plum Duo Infusion System's serial number against the list of affected numbers provided in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide - US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 37 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1094-2026 (December 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1094-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.