HistoCore PELORIS 3 — Class II medical device recall Z-1683-2025
Ongoing recall by Leica Biosystems Melbourne Pty Ltd, reported 2025-05-07, distributed in AZ, CA, FL, MN, NC, NJ, NY, OH…. There is a leakage issue associated with the tubing in the manifold of the instrument.
| Recall number | Z-1683-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leica Biosystems Melbourne Pty Ltd, Mount Waverley, Australia |
| Recall initiated | 2025-04-02 |
| Classified | 2025-04-28 |
| Reported by FDA | 2025-05-07 |
| Distributed | AZ, CA, FL, MN, NC, NJ, NY, OH, PA, TN, TX, UT, VA, WI |
| Quantity | 77 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 09349458004811 |
| Serial numbers | 45111064, 45111065, 45111067, 45111068, 45111069, 45111070, 45111071, 45111073, 45111074, 45111075, 45111076, 45111077, 45111078, 45111079, 45111080, 45111081, 45111082, 45111084, 45111086, 45111087, 45111088, 45111089, 45111090, 45111091, 45111092 and 79 more |
| Model numbers | 45.0005/45.7512.501, A11 |
Product
HistoCore PELORIS 3, Model/Catalog Number: 45.0005/45.7512.501 A11, Software Version: 3.4.0. The HistoCore PELORIS 3 Rapid Tissue Processor is a dual retort rapid tissue processor used to prepare tissue samples.
Reason for recall
There is a leakage issue associated with the tubing in the manifold of the instrument.
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-1683-2025. 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.