LEICA BIOSYSTEMS NUSSLOCH GMBH: FDA recalls
FDA enforcement reports name LEICA BIOSYSTEMS NUSSLOCH GMBH as the recalling firm in 5 events. The events have 10 product records. The recalls started from 2023 to 2025. All the events are device recalls.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Enforcement events
5 events, newest first.
| Initiated | Product (first record) | Type | Class | Records | Status |
|---|---|---|---|---|---|
| 30 Jan 2025 | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01 | Device | Class II | 1 | Ongoing |
| 4 Sep 2024 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples | Device | Class II | 6 | Ongoing |
| 10 May 2024 | Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. | Device | Class II | 1 | Ongoing |
| 10 Apr 2024 | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | Device | Class II | 1 | Ongoing |
| 20 Nov 2023 | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | Device | Class II | 1 | Ongoing |
An event with 1 product record and a class that is not Class I has no page. It has a row in this table.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Recalling firm: The firm that the FDA record names for a recall.
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Type and class
| Type | Events |
|---|---|
| Device | 5 |
| Class | Events |
|---|---|
| Class II | 5 |
- Share of the events of the firm in Class I
- 0%
- Share of all events on the register in Class I
- 18%
- Events with the status Ongoing
- 5
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Events by year
Official channels
- FDA enforcement reportsThe FDA search of the weekly enforcement reports.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA: report a problemThe FDA page that shows where a report about a product goes.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
Cite this page
Recall Register. LEICA BIOSYSTEMS NUSSLOCH GMBH: FDA recalls. https://recallregister.com/firm/leica-biosystems-nussloch-gmbh/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- State of the firm address
- N/A
The firm name is the spelling in the FDA records. A company with 2 spellings has 2 pages.
A firm with more products can have more recalls. This site does not compare one firm with a different firm. How the register is made. Report an error.
Questions
- Which classes do the FDA recalls of LEICA BIOSYSTEMS NUSSLOCH GMBH have?
- Class II: 5 events. The class is for the product of a recall. It is not a class of the firm.
- What is the newest FDA recall of LEICA BIOSYSTEMS NUSSLOCH GMBH?
- FDA event 96220, which the firm started on 30 Jan 2025. The first product in the record is:
Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
- How many FDA recalls of LEICA BIOSYSTEMS NUSSLOCH GMBH have the status Ongoing?
- 5 events have the status Ongoing in the openFDA file. openFDA says about the status:
FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.