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Stop using now Medical device recall · FDA · Published May 3, 2019

Leica Cryostats Recall: Flammable Freezing Sprays Risk Serious Injury

Leica Microsystems recalls cryostats with serial numbers from 7466 down that use flammable freezing sprays, which can ignite and cause serious injuries. Affected users should stop using the device immediately.

🇺🇸 FDA recall #Z-1729-2019Medical deviceLeica ›
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Recalling firmLeica Microsystems, Inc.1700 Leider Ln · Buffalo Grove, IL 60089-6622
✎ GovInfoNow plain-language explainer

Leica Microsystems is recalling cryostats used for freezing samples in labs and medical settings. The devices may have flammable freezing sprays that can ignite, causing serious injuries if not properly labeled. Read more at govinfonow.com/recall/67958-leica-cryostats-recall-flammable-freezing-sprays-risk-serious-injury.

Source Summary by GovInfoNow · govinfonow.com/recall/67958-leica-cryostats-recall-flammable-freezing-sprays-risk-serious-injury · Updated August 20, 2026 · FDA enforcement record: FDA #Z-1729-2019

Cite this page

“Leica Cryostats Recall: Flammable Freezing Sprays Risk Serious Injury.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67958-leica-cryostats-recall-flammable-freezing-sprays-risk-serious-injury. Based on FDA recall #Z-1729-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1729-2019%22&limit=1).

The FDA announced on May 3, 2019, that Leica Microsystems, Inc. is recalling Leica Cryostats due to labeling that omits warnings about flammable freezing sprays. The agency said the missing warning could allow users to ignite the sprays, potentially causing serious injuries.

How to tell if you have it

  • Leica CM1950 (serial numbers 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 (serial numbers 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 (serial numbers 1450; 1448; 1446 to 1444; 1442; 1439; 1437; and all devices with serial number lower than 1437)
  • Leica CM3050 S (serial numbers 7398; 7396 to 7394; 7392; 7398 to 7387; 7385 to 7381; 7379; and all devices with serial number lower than 7379)
  • Leica CM1850UV (serial numbers 2822; and all devices with serial number lower than 2822)
  • Leica CM1850 (serial numbers 7265; and all devices with serial number lower than 7265)
  • Leica CM1510 S (serial numbers 6600; and all devices with serial number lower than 6600)
  • Leica CM1100 (serial numbers 1418; and all devices with serial number lower than 1418)

The hazard

According to the FDA, the current labeling for the recalled Leica Cryostats does not include specific warnings regarding the use of flammable freezing sprays. The agency stated that such sprays can potentially ignite and cause serious injuries.

Context

GovInfoNow's records show Leica Microsystems, Inc. has had 15 other recalls on record since June 19, 2017. Other recent recalls of similar products include the Erbe Flexible Cryoprobe Recall (Feb. 12, 2026), the Glypto Cryo Machine Recall (Aug. 24, 2026), and the Lutronic DermaV Laser System Recall (Aug. 6, 2026).

How to tell if you have this one

Check the serial number on your Leica cryostat. Affected models include Leica CM1950, CM1860/UV, CM1520, CM3050 S, CM1850UV, CM1850, CM1510 S, and CM1100 with specific serial number ranges as listed in the recall.

  • Brand
    Leica
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using It Now

    Immediately stop using the cryostat if it has the affected serial numbers listed in the recall.

Where it went and when

Where it was distributed

Distributed in 50 states and D.C., and outside the U.S.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: 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.

Recall timeline

FDA terminated this recall 4.4 years after the firm started it.

1. Firm started the recall: May 3, 201912. FDA classified it Class II: Jun 4, 201923. Published in FDA’s Enforcement Report: Jun 12, 201934. FDA terminated the recall: Sep 28, 2023420192023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1729-2019 (May 3, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1729-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA