Lower riskMedical device recall · FDA · Published December 15, 2025
ICU Medical Plum Duo Infusion Pump Recall: Flush Error Messages May Prevent Therapy
ICU Medical recalls Plum Duo Infusion Pumps with specific list numbers and software versions due to potential flush errors during piggyback therapy that may prevent treatment. Affected units must be checked for error messages.
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
Take action
Contact the company
📍Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835
“ICU Medical Plum Duo Infusion Pump Recall: Flush Error Messages May Prevent Therapy.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50436-icu-medical-plum-duo-infusion-pump-recall-flush-error-messages. Based on FDA recall #Z-1118-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1118-2026%22&limit=1).
The FDA announced on Dec. 15, 2025, that ICU Medical, Inc. is recalling the Plum Duo Infusion Pump due to a software issue that may prevent clinicians from programming a necessary flush. According to the FDA, this defect could interfere with therapy delivery.
How to tell if you have it
Brand: ICU Medical
Product: Plum Duo Infusion Pump
List Numbers: 400020401 (US), 400021001 (Philippines)
According to the FDA, the pump includes a feature that automatically flushes the downstream line after piggyback therapy. In certain cases, clinicians may receive an Upper Hard Limit or Lower Hard Limit Violation message when programming this flush, which prevents it from being programmed.
Context
GovInfoNow's records show ICU Medical, Inc. has issued 60 other recalls since June 15, 2017. Recent brand recalls include the Aug. 20, 2026 CADD Yellow Medication Cassette Reservoir Recall and the June 24, 2026 Hotline Fluid Warming Set Recall. Other recent recalls of similar products include the Baxter Novum IQ Syringe Pump Recall (Aug. 11, 2026), the Fresenius Kabi Ivenix Infusion Pump Recall (Nov. 3, 2025), and the Spectrum IQ Infusion Pump Recall (Jan. 13, 2026).
How to tell if you have this one
Check for list numbers 400020401 (US) or 400021001 (Philippines) and software versions 1.1.0 to 1.1.4. The pump may show an error message when programming a piggyback flush.
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 distribution - US Nationwide and the country of Philippines.
Recall number
Product, codes & lots
Quantity
Z-1118-2026
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines); 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
—
Z-1119-2026
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines); 400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0
—
Z-1120-2026
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines); 400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
—
Based on the official FDA remedy
What to do — step by step
Check for Error Messages
Look for Upper Hard Limit (UHL) or Lower Hard Limit (LHL) violation messages when programming a piggyback flush.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the country of Philippines.” 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 44 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-1118-2026 (December 15, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1118-2026 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.