Leica HistoCore PEGASUS Tissue Processor — Class II medical device recall Z-1947-2024
Ongoing recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, reported 2024-06-12, distributed nationwide. Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding
| Recall number | Z-1947-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEICA BIOSYSTEMS NUSSLOCH GMBH, Nussloch, N/A, Germany |
| Recall initiated | 2024-04-10 |
| Classified | 2024-06-04 |
| Reported by FDA | 2024-06-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 141 devices |
| UPC / GTIN / UDI-DI | 04049188216397 |
| Serial numbers | G0061, G0154, G0156, G0530, G0532, G0779, G0781, G0782 |
| Model numbers | 14048858005 |
Product
Leica HistoCore PEGASUS Tissue Processor, REF 14048858005.
Reason for recall
Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximum fill level marks on reagent bottles or in the paraffin tanks.
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-1947-2024. 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.