Quick Facts at a Glance
- Recall Date
- December 15, 2025
- Hazard Level
- HIGH
- Brand
- ICU Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- ICU Medical
- Product type
- Infusion Pump
- Model numbers
- 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 15, 2025
Reported by FDA DEVICE
January 28, 2026
RecallRadar source check
February 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact ICU Medical, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The ICU Medical Plum Duo Infusion Pump is used in medical settings to deliver medication intravenously. It features a programmed flush system to clear the line after piggyback therapy, ensuring accurate dosing.
Why This Is Dangerous
The hazard arises when the pump fails to deliver the programmed flush due to violation messages, which can lead to incorrect medication delivery and potential risks to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients relying on this infusion pump may face risks associated with improper medication delivery, necessitating immediate discontinuation and contact with healthcare providers.
Practical Guidance
How to identify if yours is affected
- Check the model number and software version on your device.
- Verify against the recalled model numbers listed in the recall notice.
- Inspect any notifications received from the manufacturer or healthcare provider.
Where to find product info
Model numbers can typically be found on the device label or packaging, while software versions are usually accessible in the device settings.
What timeline to expect
Expect a timeline of 4-6 weeks for processing any refunds or replacements after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Follow up via phone or email if no response is received within a week.
- Consider contacting relevant health authorities if issues persist.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Consult with healthcare providers about device safety and recall status.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any notifications received regarding the recall for your records.
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Product Details
The recall involves ICU Medical's Plum Duo Infusion Pump, List Numbers: 400020401 (US) and 400021001 (Philippines). The affected software versions include 1.1.0, 1.1.1, 1.1.2, 1.1.3, and 1.1.4. These devices were distributed worldwide.
Key Facts
- Recall date: December 15, 2025
- Report date: January 28, 2026
- Hazard level: High
- Software versions: 1.1.0 to 1.1.4
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Safety Guide
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