CLASS II ONGOING Device recall · Reported 23 Oct 2024 · FDA Enforcement Report
Leica Biosystems Cryostat recalled
Leica Biosystems Nussloch is recalling Leica Biosystems Cryostat, distributed nationwide in the US. The recall was initiated on 4 Sep 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0086-2025
- FDA event ID
- 95323
- Recalling firm
- Leica Biosystems Nussloch, Nussloch
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2024
- FDA classified
- 15 Oct 2024
- Reported
- 23 Oct 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 4 Sep 2024 | Recall initiated by company | |
| 15 Oct 2024 | Classified by FDA | +41 days |
| 23 Oct 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples
Where it was distributed
US Nationwide distribution.
Questions about this recall
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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 95323This product is part of a recall event; the main page for the event is Leica Biosystems Cryostat recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide | |
| CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide | |
| CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide | |
| CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide | |
| CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide |
More recalls from Leica Biosystems Nussloch
All 10| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Leica Biosystems Cryostats CM1950 recalled | Leica Biosystems Nussloch | Device Malfunction | Nationwide |
| Device | CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide |
| Device | CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide |
| Device | CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide |
| Device | CLASS II | Leica Biosystems Cryostat recalled | Leica Biosystems Nussloch | Other | Nationwide |
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