Plum Duo Infusion System — Class I medical device recall Z-2129-2025
Ongoing recall by ICU Medical, Inc., reported 2025-08-13, distributed nationwide. ICU Medical identified two sequences of programming events and alarm interactions that may cause the user inte
| Recall number | Z-2129-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., Lake Forest, IL, United States |
| Recall initiated | 2025-07-11 |
| Classified | 2025-08-06 |
| Reported by FDA | 2025-08-13 |
| Distributed | Nationwide (US) |
| Quantity | 4,677 units |
| Serial numbers | 50000124, 50000125, 50000126, 50000127, 50000128, 50000129, 50000130, 50000131, 50000132, 50000133, 50000134, 50000135, 50000136, 50000137, 50000138, 50000139, 50000140, 50000141, 50000142, 50000143, 50000144, 50000145, 50000146, 50000147, 50000148 and 475 more |
Product
Plum Duo Infusion System, List Number: 400020401
Reason for recall
ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2129-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.