FDA Device recall Z-0090-2025
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03
- FDA Device
- Class II
- ongoing
- Published 2024-10-23
On 2024-10-23 the FDA classified a Class II recall of Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03 by Leica Biosystems Nussloch, citing 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 poten….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0090-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-09-04 |
| Published | 2024-10-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Leica Biosystems Nussloch |
| Distribution | US |
Product
Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples
Reason
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.
Identifiers
| code_info | a) Material Number 14047033518, UDI/DI 04049188065599, Serial Numbers: 5013012008, 3151052002, 3559082003; b) Materia…a) Material Number 14047033518, UDI/DI 04049188065599, Serial Numbers: 5013012008, 3151052002, 3559082003; b) Material Number 14903050S01, UDI/DI 04049188003270, Serial Numbers: 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, 5104052008, 3009012002, 4142, 4014112004, 2421022000, 3376, 3901072004, 3163052002, 3917072004, 2781042001, 4223052005, 4301092005, 5131062008, 4724022007, 2676112000, 3589092003, 4145, 4569082006, 3508, 2533062000, 4311092005, 4317092005, 4335092005, 4795052007, 5207, 4573082006, 515207200 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0090-2025%22
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