FDA recall notice
Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System…
FDA Recall Confirmed · Infusion Pump · posted Aug 28, 2025
Key facts
| Notice | Infusion Pump Correction: ICU Medical, Inc. Issues Correction for Plum Duo Infusion System Due to Software Possibly Resulting in Pump Becoming Unresponsive |
|---|---|
| Device type | Infusion Pump |
| Status | Recall Confirmed |
| Posted | Aug 28, 2025 |
| Notice on fda.gov | fda.gov |
At a glance
- Confirmed Recall confirmed
- Yes Currently listed by the FDA
- 1–9 Recall events referenced
- 1–9 UDI device identifiers named
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recall notices and early alerts
The FDA's Medical Device Recalls and Early Alerts list covers the most serious device recalls, plus early alerts about potentially high-risk device issues while the FDA is still collecting information. A notice is updated as the recall is confirmed or changes.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls and Early Alerts · Source date: