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FDA recall, , Moderate risk

Plum Duo Infusion, Duo Precision IV, and Solo Precision IV Pump

The Plum Solo Precision IV Pump may not display a soft limit alert, potentially leading to under- or over-delivery.

What happened

ICU Medical, Inc. of Lake Forest, Illinois recalled its Plum Duo Precision IV Pump, Plum Duo Infusion Pump, and Plum Solo Precision IV Pump. Under certain conditions, the pump may not display a soft limit alert and will not notify the clinician of a soft limit violation before confirming and starting delivery, which may potentially lead to under- or over-delivery. The recall began on April 29, 2026, and was added to the FDA's Enforcement Report on June 5, 2026.

What to do

We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:

  1. A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
  2. Talk to your health care provider before you stop using it.

Is yours affected?

3 products

Compare these details with yours, then check the recall notice to see which units are recalled.

  1. Plum Duo Precision IV Pump, 40002-0403

  2. Plum Duo Infusion Pump, 40002-0401

  3. Plum Solo Precision IV Pump, 40001-0401

Recall details

Company began the recall
Sold in

Worldwide - US Nationwide distribution in the states of Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, New Mexico, New York, Pennsylvania, Tennessee, Texas and the country of Canada.

Company
ICU Medical, Inc.Lake Forest, Illinois
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
98872
Recall numbers
Z-2311-2026 to Z-2313-2026

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.

  1. Company began the recall

  2. Added to FDA's Enforcement Report · Classified by FDA

  3. Listed on Recall Canary

  4. In FDA's weekly enforcement report

  5. Summary updated

Summary by Recall Canary, written with AI · summary updated Oct 2, 2026 · primary source: U.S. Food and Drug Administration (opens in a new tab)