Leica HistoCore PEGASUS — Class II medical device recall Z-0590-2024
Ongoing recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, reported 2024-05-01, distributed nationwide. There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS /
| Recall number | Z-0590-2024 |
|---|---|
| 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 | 2023-11-20 |
| Classified | 2023-12-19 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 98 devices |
| Serial numbers | G0061-G0701 |
Product
Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED)
Reason for recall
There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore PEGASUS Plus resulting from an incorrect assignment of the carryover value set for created or edited protocols.
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-0590-2024. 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.