Leica Biosystems recalls CM1950 cryostats with specific material numbers due to risk of serious injury from flammable freezing sprays used in chamber without proper warnings.
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 CM1950 cryostats that may have been used with flammable freezing sprays. This poses a serious injury risk if the sprays ignite, which can happen if the cryostat's labeling didn't warn about flammable sprays before 2019.
The cryostat chamber can ignite flammable freezing sprays if they are used without proper warnings. The hazard was identified because the labeling did not include warnings about flammable sprays prior to 2019, increasing the risk of serious injury.
Users of Leica Biosystems CM1950 cryostats with specific material numbers are affected. Laboratory technicians and pathologists using these devices are most at risk due to potential fire or injury from flammable sprays.
Check for material numbers: 14047742467, 1491950C1US, 1491950C2US, or 1491950C3US. These models were sold with specific serial numbers and were used before 2019 without warnings about flammable sprays.
Look for material numbers 14047742467, 1491950C1US, 1491950C2US, or 1491950C3US on the cryostat.
The cryostat may have been used with flammable freezing sprays without proper warnings, which can ignite and cause serious injury.
Material numbers 14047742467, 1491950C1US, 1491950C2US, and 1491950C3US.
The official recall does not specify a remedy, so users should check if they have the affected material numbers and contact Leica Biosystems for further guidance.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0089-2025 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-0089-2025 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.
