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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82425

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
May 03, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Leica Microsystems, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1729-2019
Recall number
Z-1729-2019
Initiated
May 03, 2019
Classification
Class II
Status
Terminated
Recalling firm
Leica Microsystems, Inc.
Quantity
17,179 devices total (4,835 US, 12,344 OUS)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.