# FDA recall Z-0085-2025

> **LEICA BIOSYSTEMS NUSSLOCH GMBH** · Class II · device recall initiated 2024-09-04.

## Product

Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples

## Reason for recall

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0085-2025
- **Recalling firm:** LEICA BIOSYSTEMS NUSSLOCH GMBH
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-04
- **Report date:** 2024-10-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Nussloch, Germany

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0085-2025

## Citation

> AI Analytics. FDA recall Z-0085-2025. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0085-2025. Source: US FDA. Licensed CC0.

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