FDA recall record · openFDA

LEICA BIOSYSTEMS NUSSLOCH GMBH

10 FDA recalls on record (2023–2025) — 10 device. 10 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within th 6

There is an issue regarding poorly processed and/or damaged biopsy tissue specimens on the HistoCore PEGASUS / HistoCore 1

Firm became aware of software issues related to most recent firmware update which could result in loss of patient tissue 1

Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent levels exceeding the maximu 1

An issue with safe usage of the device was identified whereby toxic smoke and internal fire developed resulting from a p 1

Recalls

Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmw Class II 2025-01-30 Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 149 Class II 2024-09-04 Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples Class II 2024-09-04 Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. Class II 2024-04-10 Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, Class II 2024-09-04 Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 1 Class II 2024-09-04 Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sect Class II 2024-09-04 Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 149 Class II 2024-09-04 Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. Class II 2024-05-10 Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) Class II 2023-11-20

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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