# FDA recall Z-1683-2025

> **Leica Biosystems Melbourne Pty Ltd** · Class II · device recall initiated 2025-04-02.

## 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.

## Distribution

US States: AZ, CA, FL, MN, NJ, NY, NC, OH, PA, TN, TX, UT, VA, and WI.

## Key facts

- **Recall number:** Z-1683-2025
- **Recalling firm:** Leica Biosystems Melbourne Pty Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-04-02
- **Report date:** 2025-05-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mount Waverley, N/A, Australia

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1683-2025

## Citation

> AI Analytics. FDA recall Z-1683-2025. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-1683-2025. Source: US FDA. Licensed CC0.

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