Leica Biosystems recalls CM1850 cryostats with specific material numbers due to risk of serious injury from flammable freezing sprays used in the chamber before 2019.
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.
Leica Biosystems is recalling certain CM1850 cryostats because some users may be using flammable freezing sprays inside the chamber. These sprays can ignite, causing serious injuries. The recall focuses on units sold before 2019 that lack specific warnings about this hazard.
The cryostat chamber may contain flammable freezing sprays that can ignite if used. This risk is higher when the sprays are used without proper warnings, as the chamber labeling did not include specific warnings about flammable sprays prior to 2019.
Users of Leica Biosystems CM1850 cryostats who use flammable freezing sprays in the chamber are affected. Laboratory technicians and pathologists working with tissue samples are most at risk.
Check for material numbers: 14047131148, 14901850001, 14901850001R0501, or 1491850UVUL. The recall applies to units sold before 2019 that lack specific warnings about flammable freezing sprays.
Ensure no flammable freezing sprays are used in the cryostat chamber before taking further action.
Check if the cryostat has a label warning about flammable freezing sprays, which was not included prior to 2019.
Leica Biosystems recognized that some customers use flammable freezing sprays in the cryostat chamber, which can ignite and cause serious injuries. The chamber labeling did not include specific warnings about this hazard before 2019.
Material numbers: 14047131148, 14901850001, 14901850001R0501, and 1491850UVUL.
No, but you should check for flammable freezing sprays and ensure they are not used in the chamber. The recall does not require immediate discontinuation of use.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0087-2025 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-0087-2025 from Leica Biosystems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
