FDA Device recall Z-2312-2026
Plum Duo Infusion Pump, 40002-0401
- FDA Device
- Class II
- ongoing
- Published 2026-06-17
On 2026-06-17 the FDA classified a Class II recall of Plum Duo Infusion Pump, 40002-0401 by Icu Medical, citing under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This ma….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2312-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-29 |
| Published | 2026-06-17 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Icu Medical |
| Distribution | US |
Product
Plum Duo Infusion Pump, 40002-0401
Reason
Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.
Identifiers
| code_info | UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2312-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.