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
- 400020403 (US), Software Versions: 1.2.2, 400021003 (Philippines), Software Versions: 1.2.0
- 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 Plum Duo Precision IV Pump is used in healthcare settings to deliver medications intravenously. It features a programmed flush feature that is intended to automatically clear the line after piggyback therapy, which is common in fluid administration.
Why This Is Dangerous
The device may improperly deliver flush volumes, leading to potential medication errors. This could result in serious health risks for patients receiving treatment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Users must stop using the device immediately, which can disrupt patient care. The urgency of addressing this recall ensures patient safety during medication administration.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device.
- Verify the software version matches 1.2.2 or 1.2.0 for affected models.
- Look for recall notification letters from ICU Medical.
Where to find product info
The model number and software version are typically located on the back or bottom of the IV pump.
What timeline to expect
Expect to receive instructions from ICU Medical within 4-6 weeks regarding the recall process.
If the manufacturer is unresponsive
- Contact ICU Medical directly through their customer service line.
- Follow up with your healthcare provider for assistance.
How to prevent similar issues
- Always check for recalls before using medical devices.
- Verify that the device has the latest software updates.
- Consult healthcare professionals for device safety prior to use.
Documentation advice
Keep records of all correspondence with ICU Medical, including emails and phone call notes. Document any issues encountered with the device for future reference.
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Product Details
The recall includes Plum Duo Precision IV Pumps, List Numbers: 400020403 (US), 400021003 (Philippines). The affected software versions are 1.2.2 and 1.2.0. The device has been distributed worldwide.
Key Facts
- Recall date: December 15, 2025
- Classification: Class II
- Immediate action required
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Safety Guide
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