FDA recall, , Moderate risk
ICU Medical Plum Duo and Plum Solo Infusion Pumps
ICU Medical Plum Duo and Plum Solo Infusion Pumps can prevent programming a piggyback flush, causing a violation message.
Summary by Recall Canary from the FDA notice
What happened
ICU Medical, Inc. of Lake Forest, Illinois recalled the Plum Solo Precision IV Pump, the Plum Duo Precision IV Pump, and the Plum Duo Infusion Pump beginning December 15, 2025. The recall was added to the FDA's Enforcement Report and classified on January 16, 2026. The 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. Distribution was worldwide, including the US Nationwide and the country of Philippines.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
3 products
Affected if its UDI-DI is listed.
A UDI-DI is the device identifier printed with the barcode on the device label.
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
- UDI-DI
- 400020401
- 400021001
- Affected units
- 400020401 (US), Software Versions: 1.1.1, 1.1.2, 1.1.3, 1.1.4 400021001 (Philippines), Software Versions: 1.1.0
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
- UDI-DI
- 400010401
- 400011001
- Affected units
- 400010401 (US), Software Versions: 1.0.2; 400011001 (Philippines), Software Versions: 1.0.0
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines)
- UDI-DI
- 400020403
- 400021003
- Affected units
- 400020403 (US), Software Versions: 1.2.2; 400021003 (Philippines), Software Versions: 1.2.0
Recall details
- Company began the recall
- Sold in
Worldwide distribution - US Nationwide and the country of Philippines.
- Company
- ICU Medical, Inc.Lake Forest, Illinois
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98128
- Recall numbers
- Z-1118-2026 to Z-1120-2026
All recalls from ICU Medical, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
