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.
What this means for you
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
- Hazard
- fire
- burn-injury
- missing-warning
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.
Related recalls
Same category
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03