Leica Biosystems recalls CM1510 S cryostats with specific model numbers due to risk of serious injury from flammable freezing sprays used in chamber. Affected units sold before 2019 without warning labels.
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 CM1510 S cryostats that may have been used with flammable freezing sprays. This poses a serious injury risk if the sprays ignite inside the chamber, which can happen if the cryostat was sold before 2019 without proper warnings.
Flammable freezing sprays can ignite inside the cryostat chamber, causing serious injuries like burns or fires. The hazard was not properly warned on the cryostat labels before 2019, so users might have been unaware of the risk.
Lab technicians and pathologists using the cryostats for tissue freezing are most at risk. Units sold before 2019 without specific flammable spray warnings are affected.
Check for model number CM1510 S with material numbers 491510C002 or 1491510C003. Units sold before 2019 without flammable spray warnings are affected.
Identify the model number on your cryostat to see if it matches CM1510 S with material numbers 491510C002 or 1491510C003.
Check if you have used flammable freezing sprays in the chamber, as this increases the risk of ignition.
Leica Biosystems recognized that some customers were using flammable freezing sprays in the cryostat chamber, which can ignite and cause serious injuries. The cryostat labels did not include warnings about this risk before 2019.
Check if your cryostat matches the model numbers listed. If it does, review your usage of flammable freezing sprays and contact Leica Biosystems for further guidance.
The cryostat labels did not include specific warnings about flammable freezing sprays before 2019, which is why this recall was initiated.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0086-2025 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-0086-2025 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.
