Use caution Medical device recall · FDA · Published October 22, 2024

ICU Medical: Counterfeit Batteries Risk for Plum Infusion Systems

ICU Medical recalls counterfeit batteries used with Plum Infusion Systems that may fail to hold charge, causing early battery replacement messages. Affected units lack ICU Medical Test Label and CE Mark.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0482-2025Medical device ICU Medical ›

Use caution until it’s fixed

ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.

Take action

Contact the company

Recalling firmICU Medical, Inc.600 N Field Dr · Lake Forest, IL 60045-4835

✎ GovInfoNow plain-language explainer

ICU Medical recalls counterfeit batteries that may fail to hold charge and cause the infusion pump to display early battery replacement messages. These batteries are not tested for safety and could lead to pump malfunctions. Read more at govinfonow.com/recall/53664-icu-medical-counterfeit-batteries-risk-for-plum-infusion-systems.

Source Summary by GovInfoNow · govinfonow.com/recall/53664-icu-medical-counterfeit-batteries-risk-for-plum-infusion-systems · Updated August 18, 2026 · FDA enforcement record: FDA #Z-0482-2025

Cite this page

“ICU Medical: Counterfeit Batteries Risk for Plum Infusion Systems.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53664-icu-medical-counterfeit-batteries-risk-for-plum-infusion-systems. Based on FDA recall #Z-0482-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0482-2025%22&limit=1).

The FDA announced on Oct. 22, 2024, that ICU Medical is recalling allegedly counterfeit CSB batteries used with Plum Infusion Systems due to potential failure to hold charge. The agency issued recall number Z-0482-2025 for the Class I voluntary recall.

How to tell if you have it

Brand: ICU Medical
Product: Plum Infusion Systems (Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197)
Batteries: All batteries WITHOUT ICU Medical Test Label and CE Mark on label, WITH Date code (yellow label found on side of battery): W2401xxxx - W2406xxx
Quantity: 3,840 units
Distribution: Worldwide, including US (nationwide), Puerto Rico, Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland, Jordan, Kuwait, Mexico, Netherlands, Oman, Peru, Philippines, Poland, Saudia Arabia, Spain, Taiwan, Turkey, United Kingdom, and Uruguay

The hazard

According to the FDA, preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. The batteries have not been tested or validated for use with Plum Infusion Systems.

Context

GovInfoNow's records show ICU Medical, Inc. has had 60 other recalls on record since June 15, 2017. Other recent recalls of similar products include Fresenius Kabi Ivenix Infusion System Software Recall (May 6, 2026), Medtronic DLP Cannula Recall (April 21, 2026), and Medtronic MiniMed 640G Insulin Pump Recall (July 13, 2026).

How to tell if you have this one

Check if your battery label lacks an ICU Medical Test Label and CE Mark. Counterfeit batteries have a date code (yellow label) in the range W2401xxxx to W2406xxx. Affected units include specific Plum Infusion System models listed in the recall.

Brand
ICU Medical
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Battery Label
Look for an ICU Medical Test Label and CE Mark on the battery. If missing, the battery is counterfeit and affected.

Where it went and when

Where it was distributed

Distributed nationwide, and outside the U.S.

FDA distribution: “Worldwide distribution: US (nationwide) including Puerto Rico and OUS (foreign) countries of: Argentina, Brazil, Canada, Chile, Colombia, France, Greece, Hong Kong, Italy, Ireland Jordan, Kuwait, Mexico, Netherlands, Oman, Peru,…” 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 36 days after the firm started it.

Oct 22, 2024Firm started the recall
Nov 21, 2024FDA classified it Class I
Nov 27, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Keep exploring

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Link to this recall

<a href="https://govinfonow.com/recall/53664-icu-medical-counterfeit-batteries-risk-for-plum-infusion-systems">ICU Medical: Counterfeit Batteries Risk for Plum Infusion Systems (GovInfoNow)</a>

Where this comes from

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-0482-2025 (October 22, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0482-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.