Leica Biosystems Cryostat Model Number CM1510 S — Class II medical device recall Z-0086-2025
Ongoing recall by LEICA BIOSYSTEMS NUSSLOCH GMBH, reported 2024-10-23, distributed nationwide. As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays
| Recall number | Z-0086-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | LEICA BIOSYSTEMS NUSSLOCH GMBH, Nussloch, Germany |
| Recall initiated | 2024-09-04 |
| Classified | 2024-10-15 |
| Reported by FDA | 2024-10-23 |
| Distributed | Nationwide (US) |
| Quantity | 13 units |
| UPC / GTIN / UDI-DI | 04049188002891, 04049188002945 |
| Serial numbers | 5065, 5108122004, 5269, 5330, 5359022006, 5367012006, 5467072006, 5537, 5625022007, 5667, 5901, 5913, 5996 |
| Model numbers | CM1510S |
Product
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0086-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.