The Recall Desk
SevereFDA (Devices)·Z-2129-2025·Announced 2025-08-13

Plum Duo infusion system interface may become unresponsive during programming

The Plum Duo Infusion System is being recalled because two sequences of programming events and alarm interactions may cause the user interface to become unresponsive. 4,677 units are affected.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.

Plain-English summary

The Plum Duo Infusion System, list number 400020401, UDI-DI M335400021, is being recalled. The action covers 4,677 units, identified by the serial numbers in the recall notice.

The stated reason is that ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. The FDA classified the action as Class I, its most serious classification.

Distribution was nationwide in the United States. The pumps are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected units using the list number, UDI-DI and serial numbers above and follow the instructions issued by ICU Medical.

The recalled product

Product
Plum Duo Infusion System, List Number: 400020401
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Infusion pump
Hazard
Affected units
4,677

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: M335400021

Distribution

Distributed nationwide across the United States.

Related recalls

Same manufacturer · ICU Medical, Inc.

See all →