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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices

ICU Medical Plum Solo and Duo Infusion Pumps Recalled for Software Flush Error

Agency Publication Date: January 16, 2026
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Summary

ICU Medical, Inc. is recalling various models of its Plum Solo and Duo Infusion Pumps, including the Duo, Duo Precision, and Solo Precision versions. These medical pumps have a software issue where a feature designed to automatically flush the IV line after a 'piggyback' medication delivery may fail. Clinicians may receive error messages, such as Upper or Lower Hard Limit violations, which prevent the flush from being programmed and delivered as intended.

Risk

If the automatic flush is blocked by these software errors, the full dose of medication remaining in the tubing may not be delivered to the patient, or there could be a delay in starting the next scheduled therapy. This could potentially lead to under-dosing or complications depending on the medication being administered.

What You Should Do

  1. This recall involves ICU Medical Plum Duo and Solo Infusion Pumps, including models 400020401, 400021001, 400020403, 400021003, 400010401, and 400011001. See the Affected Products section below for the full list of affected software versions.
  2. Stop using the recalled device immediately if you encounter software violations when programming flushes.
  3. Contact the manufacturer, ICU Medical, Inc., or your distributor to arrange for a software correction, device return, or replacement instructions.
  4. Call the FDA at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/medical-devices for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: ICU Medical Plum Duo Infusion Pump
Model / REF:
400020401
400021001

Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 (US); 1.1.0 (Philippines). Recall #: Z-1118-2026.

Product: ICU Medical Plum Duo Precision IV Pump
Model / REF:
400020403
400021003

Software Versions: 1.2.2 (US); 1.2.0 (Philippines). Recall #: Z-1119-2026.

Product: ICU Medical Plum Solo Precision IV Pump
Model / REF:
400010401
400011001

Software Versions: 1.0.2 (US); 1.0.0 (Philippines). Recall #: Z-1120-2026.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98128
Status: Active
Manufacturer: ICU Medical, Inc.
Sold By: authorized medical distributors; ICU Medical direct sales
Manufactured In: United States
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.