The Recall Desk
HighFDA (Devices)·Z-0086-2025·Announced 2024-10-23

Leica Biosystems Cryostat lacks warning for flammable freezing spray use

Leica Biosystems Cryostat Model CM1510 S is recalled due to missing warning labels about flammable freezing sprays, which can ignite and cause serious injury. The device labeling lacked fire hazard warnings prior to 2019.

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 an FDA Class II medical device recall for a risk-of-harm hazard involving potential fire and serious injury from flammable freezing sprays. The source text does not report any actual illnesses, injuries, or deaths, so per the rubric this is High (3) rather than Severe, consistent with the criterion for risk-of-harm products without reported harm.

Plain-English summary

Leica Biosystems is recalling the Cryostat Model Number CM1510 S (Material Numbers 1491510C002 and 1491510C003), which is used to freeze and section tissue samples in clinical and research laboratories. A total of 13 units were distributed nationwide in the US.

Post-market surveillance identified that some customers are using flammable freezing sprays inside the cryostat chamber. While flammable freezing sprays are labeled with flammability warnings, the cryostat device labeling did not include any specific warning about the use of flammable freezing sprays prior to 2019. Because all flammable freezing sprays can potentially ignite inside the chamber, they present a risk of serious injury.

The recalled product

Product
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
Manufacturer
LEICA BIOSYSTEMS NUSSLOCH GMBH
Category
Medical Device — Laboratory Equipment
Hazard
Affected units
13

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 (16)

  • a) Material Number 1491510C002
  • UDI/DI (01)04049188002945
  • Serial Numbers: 5359022006
  • 5367012006
  • 5913
  • 5996
  • 5065
  • 5625022007
  • 5467072006
  • 5901
  • 5108122004
  • 5330
  • 5269
  • 5667
  • b) Material Number 1491510C003
  • UDI/DI (01)04049188002891. Serial Numbers: 5537

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 →

Related recalls

Same manufacturer · LEICA BIOSYSTEMS NUSSLOCH GMBH

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Same hazard · fire

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