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
- IV Pump
- Model numbers
- 400010401 (US), Software Versions: 1.0.2, 400011001 (Philippines), Software Versions: 1.0.0
- 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 Solo and Duo Infusion pumps are used in healthcare settings to deliver medications and fluids intravenously. They are essential for patients requiring precise dosing and continuous infusion of therapies, particularly in critical care environments.
Why This Is Dangerous
The pumps can trigger a programming error that prevents the necessary flush after piggyback therapy. This malfunction may lead to dosing inaccuracies that could adversely affect patient health.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers must stop using the affected pumps, which can disrupt treatment plans and affect patient safety.
Practical Guidance
How to identify if yours is affected
- Check the model number on the pump for 400010401 or 400011001.
- Verify the software version; affected versions are 1.0.2 and 1.0.0.
- Confirm that the device was purchased after the recall date.
Where to find product info
The model number and software version are typically located on the device label or user manual.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements after following the recall instructions.
If the manufacturer is unresponsive
- Keep a record of all communications with the company.
- Contact your healthcare provider for assistance.
- Consider filing a complaint with the FDA if the company does not respond.
How to prevent similar issues
- Verify that any medical device purchased has up-to-date certifications.
- Always check for recalls on medical devices before use.
- Consult with healthcare professionals about the latest safety information regarding medical devices.
Documentation advice
Document all correspondence with the manufacturer, including dates, names, and details of conversations. Keep copies of any receipts or proof of purchase related to the device.
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Product Details
The affected models are ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US) and 400011001 (Philippines). These pumps were distributed worldwide. Specific software versions affected include 1.0.2 and 1.0.0.
Key Facts
- Recall date: December 15, 2025
- Report date: January 28, 2026
- Hazard classification: Class II
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Safety Guide
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