Allegedly counterfeit batteries manufactured by CSB batteries being… — Class I medical device recall Z-0482-2025
Ongoing recall by ICU Medical, Inc., reported 2024-11-27, distributed nationwide. ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems.
| Recall number | Z-0482-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ICU Medical, Inc., Lake Forest, IL, United States |
| Recall initiated | 2024-10-22 |
| Classified | 2024-11-21 |
| Reported by FDA | 2024-11-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, BR, CA, CL, CO, ES, FR, GB, GR, HK, IE, IT, JO, KW, MX, NL, OM, PE, PH, PL, TR, TW, UY |
| Quantity | 3,840 |
Product
Allegedly counterfeit batteries manufactured by CSB batteries being used with Plum Infusion Systems: Plum 360" Infusion System, Pump List Number 30010; Plum A+ & Plum A+3" Infusion Systems, Pump List Numbers: 11005, 11971, 12391, 12618, 20678, 20679, 20792, 60529, 12348, 1197
Reason for recall
ICU Medical has received reports of allegedly counterfeit CSB batteries being used with Plum Infusion Systems. While these non-OEM batteries are visually similar to the Plum batteries supplied by ICU Medical, they are in fact not the same batteries and have not been tested or validated for use with Plum Infusion Systems. Preliminary reports suggest that these non-OEM batteries fail to hold their charge and the pump may display messages to replace batteries earlier than expected. OSI Batteries and their customers are distributing these non-OEM CSB batteries without authorization from ICU Medical.
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-0482-2025. 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.