Leica HistoCore Arcadia H — Class II medical device recall Z-2529-2024
Ongoing recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, reported 2024-08-14, distributed nationwide. An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resultin
| Recall number | Z-2529-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEICA BIOSYSTEMS NUSSLOCH GMBH, Nussloch, Germany |
| Recall initiated | 2024-05-10 |
| Classified | 2024-08-07 |
| Reported by FDA | 2024-08-14 |
| Distributed | Nationwide (US) |
| Quantity | 180 devices |
| UPC / GTIN / UDI-DI | 04049188194763, 04049188205971 |
| Serial numbers | 101, 1113, 1114, 1115, 1116, 1117, 1118, 1123, 1124, 117, 1198, 1199, 120, 1200, 1201, 1202, 1203, 1204, 1205, 1206, 1207, 121, 1212, 1216, 1217 and 151 more |
| Model numbers | 14039354100, 14039357258 |
Product
Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
Reason for recall
An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a problem associated with the sealing of the paraffin tank.
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-2529-2024. 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.