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Recalls & Safety AlertsVersion 4

FDA Records Class II Recall of 12,525 ICU Medical Plum Duo Infusion Pumps

An FDA enforcement report says the pump may in a specific scenario deliver up to twice the programmed volume to be infused.

By AI ReporterUpdated Aug 7, 2026, 4:06 a.m. ET
has recalled 12,525 units of its Plum Duo Infusion Pump running software version 1.2.3, according to an FDA enforcement report carrying recall number . The record lists the reason as: The affected products are identified in the record by Item Number 400020401 and Item Number 400020403. The enforcement report gives the initiation date as 10 June 2026 and the report date as 22 July 2026, with distribution described as worldwide — US nationwide and the country of Canada. The action is listed as , so details may change as the record is updated. The FDA has classified the recall as . Under the agency's own definitions, is the middle category, used where a product may cause temporary or medically reversible harm and where the chance of serious harm is remote. The FDA's enforcement database records no other enforcement action by this firm — a matter of record that says nothing about fault in this action. The Plum Duo is not a consumer product. An infusion pump of this general-purpose, large-volume type is a bedside electromechanical instrument: a rigid housing containing a motor-driven pumping mechanism, control electronics and a programmable software interface with a display screen, mounted on an IV pole or bedside stand, according to FDA and National Library of Medicine reference material. It works with disposable administration sets that carry fluid from an IV bag to a line running to the patient, and a trained operator programs the rate and duration rather than relying on gravity. Larger units of this kind can run more than one channel. The two item numbers cited refer to specific catalogue configurations of the same pump model running a particular software version. Such pumps are professional capital equipment, bought by hospitals and other health-care facilities, held in institutional equipment inventories and operated by trained clinical staff, with the disposable tubing sets bought separately as consumables. Ordinary shoppers would not encounter or buy this item; those affected are hospitals, biomedical-engineering departments, clinicians and the patients connected to the devices in their care.

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Revision history

  1. Version 67 Aug 2026, 15:31

    Added headline and dek summarising the recall; body unchanged.

  2. Version 57 Aug 2026, 13:15

    Replaced unsourced device description with the FDA 510(k) K242115 clearance record and added source URLs for the enforcement report, classification definition and clearance record.

  3. Version 47 Aug 2026, 08:06current

    Removed unsourced 510(k)/K223607, dual-channel and home-use claims; device description now attributed to the FDA and NLM reference sources.

  4. Version 37 Aug 2026, 03:11

    Replaced unsourced manufacturer-announcement product details (touchscreen, clearance date, 2024 availability) with the FDA's own description of infusion pumps and the K223607 510(k) record.

  5. Version 26 Aug 2026, 22:52

    Replaced unsourced device-description details with the manufacturer's clearance announcement, added the 510(k) clearance date and US availability, and cited the product-background source.

  6. Version 16 Aug 2026, 18:29

    First published.

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