Leica Biosystems Nussloch Gmbh
Complete recall history across all FDA and CPSC categories — 10 total recalls
Leica Biosystems Nussloch Gmbh appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (10)
FDA medical device enforcement actions by Leica Biosystems Nussloch Gmbh
| Date | Product | Reason | Class |
|---|---|---|---|
| Jan 30, 2025 | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog N... | Firm became aware of software issues related to most recent firmware update w... | Class II |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742... | As part of our post market surveillance, we recognized that some customers ar... | Class II |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510... | As part of our post market surveillance, we recognized that some customers ar... | Class II |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 140470... | As part of our post market surveillance, we recognized that some customers ar... | Class II |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131... | As part of our post market surveillance, we recognized that some customers ar... | Class II |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, f... | As part of our post market surveillance, we recognized that some customers ar... | Class II |
| Sep 4, 2024 | Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227... | As part of our post market surveillance, we recognized that some customers ar... | Class II |
| May 10, 2024 | Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embeddi... | An issue with safe usage of the device was identified whereby toxic smoke and... | Class II |
| Apr 10, 2024 | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | Poorly processed and/or damaged biopsy tissue specimens on the device resulti... | Class II |
| Nov 20, 2023 | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | There is an issue regarding poorly processed and/or damaged biopsy tissue spe... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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