Z-0088-2025Class II

Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c)...

Name: Z-0088-2025 Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c)...
Creator: Leica Biosystems Nussloch Gmbh
Published: 2024-09-04
License: https://open.fda.gov/license/

Leica Biosystems Nussloch GmbH / initiated 2024-09-04 / Open, Classified / root cause: labeling and UDI

FDA source

LEICA BIOSYSTEMS NUSSLOCH GMBH began a recall of Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning... on 2024-09-04. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0088-2025
Classification: Class II
Status: Open, Classified
Initiated: 2024-09-04
Posted: 2024-10-15
Recalling firm: Leica Biosystems Nussloch GmbH
Product: Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples
Product code: IDP Microtome, Cryostat
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling design
Action: Leica Biosystems issued an Urgent Field Action Notice to its consignees on 09/05/2024 via mail. The notice explained the problem with the device and requested the placement of a warning sticker regarding the use of flammable freezing sprays on the device and the addition of a supplemental sheet to the current IFU. For questions, please contact: Heather Jensen, Leica Biosystems, 5205 US Highway 12, Richmond, IL 60071 USA, Tel.: +1-815-298-8371, [email protected]
Quantity in commerce: 25 units
Distribution: US Nationwide distribution.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0088-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0085-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15
Z-0086-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15
Z-0087-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15
Z-0088-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15
Z-0089-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15
Z-0090-2025	Class II	Ongoing	Voluntary: Firm initiated	2024-10-23	2024-10-15

Product code IDP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)