Leica Biosystems recalls CM3050S cryostats with specific material numbers due to risk of fire from flammable freezing sprays used in chamber. Affected units sold 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 CM3050S cryostats that may be used with flammable freezing sprays. This poses a serious injury risk if the sprays ignite inside the chamber, which can happen if the cryostat's labeling didn't warn about flammable sprays before 2019.
The cryostat chamber can ignite if flammable freezing sprays are used inside it. These sprays are labeled as flammable but the device's labeling did not warn about this risk before 2019, creating a fire hazard.
Lab technicians and researchers using the CM3050S cryostat for tissue freezing. Those who used the device before 2019 with flammable sprays are most at risk.
Check for material numbers: 14047033518, 14903050S01, 14903050S02, or 14903050S03. The device was sold before 2019 and used with flammable freezing sprays.
Look for material numbers on the device: 14047033518, 14903050S01, 14903050S02, or 14903050S03.
Do not use flammable freezing sprays inside the cryostat chamber until the manufacturer provides a fix.
The cryostat's labeling did not warn about using flammable freezing sprays before 2019, which can ignite and cause serious injuries.
Check the material numbers on your device. If it matches the recalled numbers, stop using flammable sprays and contact Leica Biosystems for guidance.
The recall record does not specify a fix or remedy, so contact Leica Biosystems directly for assistance.
We’ve drafted a message you can send Leica Biosystems to request your refund or repair — edit it as you like.
Subject: Recall Z-0090-2025 — Leica Biosystems Leica Biosystems Hello, I own a Leica Biosystems that is covered by recall Z-0090-2025 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.
