Data Foundry

Medical device recalls 2026

ICU Medical Plum Solo Precision IV Pump — Class II medical device recall Z-2724-2026

Ongoing recall by ICU Medical, Inc., reported 2026-07-22, distributed nationwide. In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery

Recall numberZ-2724-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmICU Medical, Inc., Lake Forest, IL, United States
Recall initiated2026-06-10
Classified2026-07-10
Reported by FDA2026-07-22
DistributedNationwide (US)
Countries outside the USCA
Quantity5,059 units
Serial numbers600, 60000316, 60000363, 60000375, 60000388, 60000428, 60000451, 60000469, 60000495, 60000529, 60000569, 60000580, 60000637, 60000643, 60000647, 60000652, 60000668, 60000670, 60000689, 60000692, 60000695, 60000703, 60000706, 60000710, 60000712 and 475 more
Model numbers400010401

Product

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

Reason for recall

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

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-2724-2026. 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.