Z-1729-2019Class II

Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications...

Name: Z-1729-2019 Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications...
Creator: Leica Microsystems, Inc.
Published: 2019-05-03
License: https://open.fda.gov/license/

Leica Microsystems, Inc. / initiated 2019-05-03 / Terminated / root cause: design

FDA source

Leica Microsystems, Inc. began a recall of Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications on 2019-05-03. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1729-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-03
Posted: 2019-06-04
Terminated: 2023-09-28
Recalling firm: Leica Microsystems, Inc.
Product: Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Product code: IDP Microtome, Cryostat
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.
Root cause tag: design
FDA root cause: Device Design
Action: Leica Biosystems notified consignees of the recall on about 05/03/2019 via "Urgent: Medical Device Recall for Cryostat Devices" letter. Instructions included to immediately attach the provided adhesive label onto the devices and add a supplemental sheet to the current instructions for use (IFU). Consignees were also instructed to provide the recall notification to all employees who need to be aware within the organization or any organization where the affected devices have been transferred, and to complete and return the response form. The form can be faxed to +1 847-236-3747 or emailed to LMGRA@ leica-microsystems.com Questions or concerns can be directed to Adam Blunier at [email protected]. On 09/16/2019, Leica Biosystems provided an updated "Urgent: Medical Device Recall for Cryostat Devices" letter to all affected customers. The letter contained the same instructions, but instructed customers that enlarged, updated adhesive labels were provided and should be applied to affected equipment on top of the previously provided smaller label.
Quantity in commerce: 17,179 devices total (4,835 US, 12,344 OUS)
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.
Product codes and lots: Leica CM1950 - All devices with serial number: 8092; 8091; 8089 to 8087; 8081; 8078; 8077; 8073; 8071 to 8067; 8064 to 8062; 8058 to 8053; 8051 to 8049; 8047; 8043; 8040; 8038 to 8033; 8031 to 8025; 8023 to 8004; 8002 to 7940; 7938 to 7892; 7890 to 7469; 7466; and all devices with serial number lower than 7466. Leica CM1860/UV - All devices with serial number: 4201; 4200;4196; 4193; 4192; 4188; 4186 to 4184; 4180; 4179; 4173 to 4170; 4168; 4166 to 4160; 4158; 4157; 4154 to 4152; 4149; 4147; 4145 to 4135; 4133 to 4092; 4090; and all devices with serial number lower than 4090. Leica CM1520 - All devices with serial number: 1450; 1448; 1446 to 1444; 1442; 1439; 1437; and all devices with serial number lower than 1437. Leica CM3050 S - All devices with serial number: 7398; 7396 to 7394; 7392; 7398 to 7387; 7385 to 7381; 7379; and all devices with serial number lower than 7379. Leica CM1850UV - 2822; and all devices with serial number lower than 2822. Leica CM1850 - 7265; and all devices with serial number lower than 7265. Leica CM1510 S - 6600; and all devices with serial number lower than 6600. Leica CM1100 - 1418; and all devices with serial number lower than 1418

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1729-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1729-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code IDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)