Agency classClass IIOur severity:High FDA (Devices)·Z-0087-2025·Announced 2024-10-23

Leica Cryostat Model CM1850 Lacks Fire-Risk Warning for Flammable Sprays

Leica Biosystems is recalling Cryostat Model CM1850 (322 units, US nationwide) due to missing warnings about fire hazard from flammable freezing sprays. The device's labeling prior to 2019 did not warn users that flammable sprays used in the chamber can ignite and cause serious injuries.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where serious injury from fire is possible, but no illnesses or injuries have been reported. The device is FDA Class II with a critical labeling deficiency. Per the severity rubric, risk-of-harm products without reported injuries score at most 3 (High).

Plain-English summary

Leica Biosystems is recalling Cryostat Model CM1850, a laboratory medical device used for freezing and sectioning tissue samples. The recall affects 322 units distributed nationwide in the United States. The device is sold under four material numbers: 14047131148, 14901850001, 14901850001R0501, and 1491850UVUL.

The cryostat labeling prior to 2019 did not include specific warnings about flammable freezing sprays. During post-market surveillance, Leica discovered that some customers were using flammable freezing sprays inside the cryostat chamber. Flammable freezing sprays can ignite within the device, potentially causing serious injuries. Although the spray labels indicate flammability, the cryostat device itself lacked warning about this hazard.

The recalled product

Product: Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH
Category: Medical Device — Laboratory Equipment
Hazard: fire
burn-injury
missing-warning
Affected units: 322

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

a) Material Number 14047131148
UDI/DI 04049188064790
Serial Numbers: 598061998
1874062001
329111997
370121997
175081997
517041998
376021998
702071998
2935062002
333041998
693071998
3524062003
b) Material Number 14901850001
UDI/DI 04049188003423
Serial Numbers: 1922112000
2396082001
2032122000
1850092000

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by LEICA BIOSYSTEMS NUSSLOCH GMBH under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · LEICA BIOSYSTEMS NUSSLOCH GMBH

See all →

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Leica Cryostat Model CM1100 Recalled for Fire Risk from Flammable Freezing Sprays
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Same hazard · fire