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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

ICU Medical Plum Duo Infusion System Recalled for Unresponsive User Interface

Agency Publication Date: August 6, 2025
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Summary

ICU Medical, Inc. is recalling 4,677 units of the Plum Duo Infusion System (List Number: 400020401). Two specific sequences of programming events and alarm interactions can cause the device's user interface to become unresponsive or freeze. This malfunction can prevent healthcare providers from making necessary adjustments to medication delivery, potentially delaying critical treatment or resulting in incorrect dosages. The firm initiated the recall via a notification letter on July 11, 2025.

Risk

The software defect causes the screen and controls to freeze, which may stop or delay the delivery of medications and fluids. In critical care settings, such delays can lead to serious patient harm or death if a healthcare provider cannot intervene and correct the infusion settings.

What You Should Do

  1. This recall affects ICU Medical Plum Duo Infusion Systems (List Number 400020401) manufactured in the United States and distributed nationwide.
  2. Identify if your device is affected by checking the List Number (400020401) and Serial Number on the product label. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled device and immediately move patients to a replacement infusion pump if one is available.
  4. Contact ICU Medical, Inc. directly for further instructions regarding the software correction or to arrange for a device return, replacement, or repair.
  5. Healthcare facilities should follow the instructions provided in the manufacturer's notification letter sent on July 11, 2025.
  6. If you have additional questions, call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer correction or repair

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Plum Duo Infusion System
Model / REF:
400020401
Serial Numbers (4671):
50000124
50004386
50006225
50000300
50003767
50006228
50004719
50005562
50001512
50002063
50002087
50000125
50004387
50006224
50001628
50003768
50006227
50004720
50005566
50001513
50002064
50002091
50000126
50004389
50006223
50001785
50003775
50006218
50004722
50005572
50001514
50002065
50002107
50000127
50004390
50006220
50002461
50003776
50006205
50004725
50005619
50001515
50002066
50002114
50000128
50004391
50006217
50002491
50003785
50006198
UDI:
M335400021

List Number: 400020401; Quantity: 4677 units

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97186
Status: Active
Manufacturer: ICU Medical, Inc.
Sold By: Authorized medical device distributors; Direct medical facility sales
Manufactured In: United States
Units Affected: 4677 units
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.