Data Foundry

Medical device recalls 2024

Plum 360/A+ spare batteries — Class I medical device recall Z-2449-2024

Ongoing recall by ICU Medical Inc, reported 2024-08-21, distributed nationwide. Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity

Recall numberZ-2449-2024
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmICU Medical Inc, Lake Forest, IL, United States
Recall initiated2024-05-07
Classified2024-08-09
Reported by FDA2024-08-21
DistributedNationwide (US)
Countries outside the USAE, AU, CA, ES, FR, GB, GT, IE, IT, OM, PY, QA, SA, TR, TW, UY, ZA
Quantity130,826 units
Lot numbers13492940, 13498252, 13498259, 13570187, 13588159, 13588161, 13588163, 13588165, 13588166, 13588168, 13588169, 13588170, 13594280, 13594281, 13594282, 13594285, 13594286, 13594287, 13594289, 13618384, 13620893, 13620897, 13620898, 13620902, 13620905, 13620909, 13638723, 13638724, 13638726, 13638727, 13638728, 13651640, 13651642, 13651671, 13651677, 13651678, 13651680, 13651685, 13651686, 13651688 and 13 more
Model numbersSUB0000864

Product

Plum 360/A+ spare batteries. Item Number: SUB0000864.

Reason for recall

Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity earlier in the battery lifecycle than expected and overall battery runtime may decrease earlier in the battery lifecycle than expected.

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-2449-2024. 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.