Use cautionMedical device recall · FDA · Published April 29, 2026
ICU Medical Plum Duo IV Pump Recall: Risk of Incorrect Drug Delivery
ICU Medical recalls Plum Duo Precision IV Pumps (40002-0403) due to potential under- or over-delivery of medications. Affected units may not alert clinicians of soft limit violations.
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Take action
Contact the company
📍Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835
“ICU Medical Plum Duo IV Pump Recall: Risk of Incorrect Drug Delivery.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/49325-icu-medical-plum-duo-iv-pump-recall-risk-of-incorrect. Based on FDA recall #Z-2313-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2313-2026%22&limit=1).
The FDA announced on April 29, 2026, that ICU Medical, Inc. is recalling Plum Duo Precision IV Pumps due to a potential hazard where the device may fail to display soft limit alerts or notify clinicians of violations before starting delivery. This failure could lead to under- or over-delivery of medication.
How to tell if you have it
Brand: ICU Medical
Product: Plum Duo Precision IV Pump
Model/Part Number: 40002-0403
UDI-DI: M335400031
Software Version: Plum Duo Precision IV Pump v1.2.3
The hazard
Under certain conditions, the pump may not display a soft limit alert and will not notify the clinician of a soft limit violation before confirming and starting delivery. This malfunction may potentially lead to under- or over-delivery of medication.
Context
GovInfoNow's records show ICU Medical has issued 60 other recalls since June 15, 2017. Recent brand recalls include the August 20, 2026 CADD Yellow Medication Cassette Reservoir Recall for leakage risk and the June 24, 2026 Hotline Fluid Warming Set Recall for leakage in specific lots. Other recent recalls of similar products include the Medtronic MiniMed 670G Insulin Pump Recall (July 13, 2026) and the Medtronic MiniMed 720G and 630G Insulin Pump Recalls (February 13, 2026).
How to tell if you have this one
Check for the model number 40002-0403 on the pump's label. The pump also has a unique identifier M335400031 for version 1.2.3.
Brand
ICU Medical
Category
Medical device
FDA recall event · 3 products
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Ongoing
Distribution
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Recall number
Product, codes & lots
Z-2311-2026
Plum Solo Precision IV Pump, 40001-0401; UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
Z-2312-2026
Plum Duo Infusion Pump, 40002-0401; UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
Z-2313-2026
Plum Duo Precision IV Pump, 40002-0403; UDI-DI M335400031 Plum Duo Precision IV Pump v1.2.3
Based on the official FDA remedy
What to do — step by step
Check Pump Model
Look for the model number 40002-0403 on the pump's label or unique identifier M335400031.
Where it went and when
Where it was distributed
Distributed nationwide and abroad; the notice names 11 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Idaho, Illinois, Indiana, Kansas, Maryland, Massachusetts, New Mexico, New York, Pennsylvania, Tennessee, Texas.
Recall timeline
FDA published this recall 49 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-2313-2026 (April 29, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2313-2026 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.