FDA Medical devices recall ·
Leica Biosystems Cryostat Model Number CM1850… recall
- Recall number
- Z-0087-2025
- Date
- (initiated September 4, 2024)
- Company / brand
- Leica Biosystems Nussloch Gmbh
Heidelberger Str. 17-19, Nussloch, Germany - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 322 units
- Hazard tags
- Fire Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples
Why was it recalled?
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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
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, 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, 5674052008, 2873052002, 915121998, 2812042002, 1742072000, 4720, 5508, 4947032006, 4137052004, 3318012003, 3357032003, 4548032005, 1110061999, 4722062005, 4721, 5507, 2925, 4129042004, 2628122001, 2509102001, 2136042001, 4118, 3508062003, 3421, 3400022003, 4180062004, 3496052003, 3321012003, 5307032007, 5620032008, 1336, 3322012003, 3980, 3276122002, 3306012003, 979021999, 2068022001, 1887092000, 3207, 1031031999, 2968072002, 2788032002, 4231072004, 794101998, 454051999, 5668, 4527022005, 952021999, 1663, 1387121999, 2172, 3760112003, 2936062002, 1076051999, 3558062003, 2939062002, 2906052002, 4264092004, 4471, 3333022003, 2363092001, 3876022004, 2586122001, 3435042003, 4252092004, 2903052002, 5064, 5755, 1856092000, 777101998, 5361, 5607, 2736022002, 2750022002, 917011999, 3689102003, 3197, 2260062001
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0087-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.