ASM Replacement Battery — Class I medical device recall Z-1567-2023
Ongoing recall by ICU Medical Inc, reported 2023-05-24. Due to a manufacturing defect from the battery supplier, affected batteries may experience a loss of capacity
| Recall number | Z-1567-2023 |
|---|---|
| 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 | 2023-03-22 |
| Classified | 2023-05-16 |
| Reported by FDA | 2023-05-24 |
| Quantity | 9,984 units |
| Lot numbers | 6036488, 6827738, 6827739, 6827740, 8408750, 8408755, 8408757 |
Product
ASM Replacement Battery, Component 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-1567-2023. 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.