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

Lot, batch or date codesa) Material Number 14045227382, UDI/DI 04049188075840, Serial Numbers: 1198121999, 383051996; b) Material Number 14901900100, UDI/DI 04049188003324, Serial Numbers: 703111997, 1018021999, 1538042001, 2058, 629071997, 2994, 1170111999, 3686102007, 3698; c) Material Number 14901900700, UDI/DI 04049188003300, Serial Numbers: 1267032000, 2602062004, 1577052001, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002; d) Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006
Quantity recalled25 units

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-0088-2025
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

Timeline

4 Sep 2024Recall initiated by company
15 Oct 2024Classified by FDA+41 days
23 Oct 2024Published 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 CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples

Where it was distributed

US Nationwide distribution.

Nationwide

Questions about this recall

Is Leica Biosystems Cryostat recalled?

Yes. Leica Biosystems Nussloch recalled Leica Biosystems Cryostat on 4 Sep 2024. The recall is Class II and its status is Ongoing. Recall number Z-0088-2025.

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 14045227382, UDI/DI 04049188075840, Serial Numbers: 1198121999, 383051996; b) Material Number 14901900100, UDI/DI 04049188003324, Serial Numbers: 703111997, 1018021999, 1538042001, 2058, 629071997, 2994, 1170111999, 3686102007, 3698; c) Material Number 14901900700, UDI/DI 04049188003300, Serial Numbers: 1267032000, 2602062004, 1577052001, 1679092001, 2542042004, 1771, 1885032002, 2682092004, 2376112003, 2774122004, 1114, 1749112001, 1997072002; d) Material Number 1491900UVU2, UDI/DI 04049188002570, Serial Numbers: 3243052006

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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