Plum Solo Precision IV Pump — Class II medical device recall Z-2311-2026
Ongoing recall by ICU Medical, Inc., reported 2026-06-17, distributed nationwide. Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a
| Recall number | Z-2311-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., Lake Forest, IL, United States |
| Recall initiated | 2026-04-29 |
| Classified | 2026-06-05 |
| Reported by FDA | 2026-06-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 13,613 |
Product
Plum Solo Precision IV Pump, 40001-0401
Reason for recall
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.
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-2311-2026. 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.