ICU Medical Plum Solos — Class II medical device recall Z-1991-2025
Ongoing recall by ICU Medical, Inc., reported 2025-06-25, distributed nationwide. Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypa
| Recall number | Z-1991-2025 |
|---|---|
| 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 | 2025-04-22 |
| Classified | 2025-06-18 |
| Reported by FDA | 2025-06-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | PH |
| Quantity | 214 units |
| Reason classes | software |
| Lot numbers | 60000001, 60000002, 60000003, 60000005, 60000006, 60000007, 60000008, 60000009, 60000010, 60000011, 60000014, 60000015, 60000016, 60000017, 60000019, 60000020, 60000021, 60000023, 60000024, 60000025, 60000026, 60000027, 60000028, 60000030, 60000032, 60000033, 60000035, 60000038, 60000039, 60000040, 60000041, 60000042, 60000044, 60000045, 60000046, 60000047, 60000048, 60000049, 60000050, 60000051 and 174 more |
| Model numbers | 400011001 |
Product
ICU Medical Plum Solos, Item number 400011001; infusion pump
Reason for recall
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
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-1991-2025. 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.