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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Diagnostic Equipment

LEICA BIOSYSTEMS NUSSLOCH GMBH: Cryostats Recalled Due to Fire and Burn Risk from Flammable Freezing Sprays

Agency Publication Date: October 15, 2024
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Summary

Leica Biosystems is recalling 578 Cryostat units, including models CM1100, CM1510 S, CM1850, CM1900, CM1950, and CM3050 S, because their labeling does not warn against using flammable freezing sprays. If a user sprays a flammable substance inside the chamber, it can ignite, causing fires or explosions in the laboratory. These medical devices are used to freeze and slice tissue samples for analysis. The affected units were manufactured in Germany and distributed across the United States before 2019 without the necessary fire safety warnings.

Risk

Flammable freezing sprays used within the cryostat chamber can be ignited by the device's electrical components or internal heating, potentially causing fire-related injuries or serious burns to laboratory personnel.

What You Should Do

  1. Check your device's model and serial number against the affected list, which includes Leica Cryostat models CM1100, CM1510 S, CM1850, CM1900, CM1950, and CM3050 S.
  2. Verify if your unit was manufactured prior to 2019 or lacks a specific warning label regarding the use of flammable freezing sprays.
  3. Immediately stop using any flammable freezing sprays inside the cryostat chamber, even if they have been used without incident in the past.
  4. Review the labeling on your current freezing sprays to determine if they are marked as flammable.
  5. Contact Leica Biosystems Nussloch GmbH or your healthcare provider for updated safety labeling, instructions, and to confirm if your specific serial number requires a corrective update.
  6. For more information, contact the FDA medical device recall hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Corrective labeling and user notification

How to: Contact your healthcare provider or the manufacturer for updated safety labeling regarding the flammability of freezing sprays and further instructions.

Affected Products

Product: Leica Biosystems Cryostat Model CM1100
Model / REF:
CM1100
Material Number 14046931130
UPC Codes:
04049188066237
Lot Numbers:
Serial Number 990
Date Ranges: Sold prior to 2019
Product: Leica Biosystems Cryostat Model CM1510 S
Model / REF:
CM1510 S
Material Number 1491510C002
Material Number 1491510C003
UPC Codes:
04049188002945
04049188002891
Lot Numbers:
5359022006
5367012006
5913
5996
5065
5625022007
5467072006
5901
5108122004
5330
5269
5667
5537
Date Ranges: Sold prior to 2019
Product: Leica Biosystems Cryostat Model CM1850
Model / REF:
CM1850
Material Number 14047131148
Material Number 14901850001
Material Number 14901850001R0501
Material Number 1491850UVUL
UPC Codes:
04049188064790
04049188003423
04049188002730
Lot Numbers (322):
598061998
1874062001
329111997
370121997
175081997
517041998
376021998
702071998
2935062002
333041998
693071998
3524062003
1922112000
2396082001
2032122000
1850092000
3728
1885
3156102002
3441032003
1684082001
3682102003
3080102002
4791
1439
3517062003
1186071999
5742
3976022004
217091997
960021999
2097022001
4660052005
3107
2805
3425032003
1884092000
729101998
1407121999
1678062000
2870052002
3346022003
1716062000
3222112002
2144042001
4211072004
1542032000
3069102002
469021998
4955032006
Date Ranges: Sold prior to 2019
Product: Leica Biosystems Cryostat Model CM1900
Model / REF:
CM1900
Material Number 14045227382
Material Number 14901900100
Material Number 14901900700
Material Number 1491900UVU2
UPC Codes:
04049188075840
04049188003324
04049188003300
04049188002570
Lot Numbers:
1198121999
383051996
703111997
1018021999
1538042001
2058
629071997
2994
1170111999
3686102007
3698
1267032000
2602062004
1577052001
1679092001
2542042004
1771
1885032002
2682092004
2376112003
2774122004
1114
1749112001
1997072002
3243052006
Date Ranges: Sold prior to 2019
Product: Leica Biosystems Cryostat Model CM1950
Model / REF:
CM1950
Material Number 14047742467
Material Number 1491950C1US
Material Number 1491950C2US
Material Number 1491950C3US
UPC Codes:
04049188053992
04049188002501
04049188002488
04049188002464
Lot Numbers:
492102008
432082008
288032008
581122008
435082008
380
215012008
427082008
218012008
287032008
216012008
291042008
524112008
451082008
420
335
476
454
398
399072008
314042008
508
249032008
318042008
429
328052008
577122008
407072008
391072008
356062008
Date Ranges: Sold prior to 2019
Product: Leica Biosystems Cryostat Model CM3050 S
Model / REF:
CM3050 S
Material Number 14047033518
Material Number 14903050S01
Material Number 14903050S02
Material Number 14903050S03
UPC Codes:
04049188065599
04049188003270
04049188003201
04049188003188
Lot Numbers (182):
5013012008
3151052002
3559082003
3641
4119012005
5212102008
4002102004
3944092004
3137042002
3683122003
5119
4125022005
4171032005
3954092004
2636102000
3847052004
4387122005
4585092006
4734022007
3951092004
3342112002
5208082008
4575092006
4521052006
2529052000
2605
4384102005
4538062006
4807
4269062005
2700122000
3157052002
4094012005
4503042006
3564082003
4654
2857072001
3874062004
2418022000
3417012003
4572082006
3349
3748022004
4850072007
4948102007
3588092003
3136042002
4415122005
4454022006
3240072002
Date Ranges: Sold prior to 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95323
Status: Active
Manufacturer: LEICA BIOSYSTEMS NUSSLOCH GMBH
Sold By: Authorized medical device distributors; Direct sales from Leica Biosystems
Manufactured In: Germany
Units Affected: 6 products (1 unit; 13 units; 322 units; 25 units; 30 units; 187 units)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.