# FDA recall Z-1729-2019

> **Leica Microsystems, Inc.** · Class II · device recall initiated 2019-05-03.

## Product

Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.

## Reason for recall

The current labelling does not include any specific warning about usage of flammable freezing sprays.  Such flammable freezing sprays can potentially ignite and can cause serious injuries.

## Distribution

Distributed to Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming.      Distributed internationally to Canada.

## Key facts

- **Recall number:** Z-1729-2019
- **Recalling firm:** Leica Microsystems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-05-03
- **Report date:** 2019-06-12
- **Termination date:** 2023-09-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buffalo Grove, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1729-2019

## Citation

> AI Analytics. FDA recall Z-1729-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1729-2019. Source: US FDA. Licensed CC0.

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