Class I — ICU Medical, Inc.
| Recalling firm | ICU MEDICAL, INC. |
|---|---|
| Registered facility | View this company's 6 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive. |
| Product | Plum Duo Infusion System, List Number: 400020401 |
| Quantity | 4677 units |
| Distribution | US Nationwide. |
| Initiated | 2025-07-11 |
| Classified | 2025-08-06 |
| Recall number | Z-2129-2025 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class I recall — ICU Medical, Inc. (Z-2129-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/97186/
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