Leica Biosystems recalls CM1100 cryostats for using flammable freezing sprays, which can ignite and cause serious injury. Affected units sold before 2019 without specific 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 its CM1100 cryostats because some users may be using flammable freezing sprays inside the machine. This can cause serious injuries like fires or burns if the spray ignites. The recall applies to units sold before 2019 that didn't have warnings about flammable sprays.
Flammable freezing sprays can ignite inside the cryostat chamber, causing fires or burns. The hazard occurs when these sprays are used without proper warnings on the machine, which was common before 2019.
Lab technicians and researchers who use the CM1100 cryostat for tissue freezing. Those who used flammable freezing sprays without checking the machine's labeling are at higher risk.
Check for the model number CM1100 and material number 14046931130. Units sold before 2019 that lack specific warnings about flammable freezing sprays are affected.
Look for warnings about flammable freezing sprays on the cryostat's label; if absent, the unit may be affected.
Do not use flammable freezing sprays inside the cryostat chamber until the manufacturer provides updated instructions.
Leica Biosystems found that some customers use flammable freezing sprays in the cryostat chamber, which can ignite and cause serious injuries. The machine's labeling did not include warnings about this before 2019.
Check if your unit has the model number CM1100 and material number 14046931130, and if it was sold before 2019 without warnings about flammable sprays. If so, stop using flammable sprays and check for updated labeling.
The recall does not specify a fix, but users should stop using flammable sprays and check for updated labeling on the machine.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0085-2025 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-0085-2025 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.
