Device recall: Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples
Class II FDA enforcement event 95323. Recall start date: . Status in the FDA record: Ongoing.
Reason for recall, in the words of FDA
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…
Class II, in the words of FDA
a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
LEICA BIOSYSTEMS NUSSLOCH GMBH started this device recall on 4 Sep 2024. The firm address in the FDA record is in Nussloch. FDA put the recall in Class II. FDA event 95323 has 6 product records. The first FDA enforcement report date is 23 Oct 2024. The record gives the status Ongoing.
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 .
Distribution
In the words of FDA.
US Nationwide distribution.
Recalling firm
LEICA BIOSYSTEMS NUSSLOCH GMBH, Nussloch, Germany.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
6 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0085-2025 | Leica Biosystems Cryostat Model Number CM1100, Material Number 14046931130, for freezing and sectioning tissue samples | 1 unit | Class II | Ongoing | 23 Oct 2024 |
| Z-0086-2025 | Leica Biosystems Cryostat Model Number CM1510 S, Material Numbers: a) 491510C002, b) 1491510C003; for freezing and sectioning tissue samples | 13 units | Class II | Ongoing | 23 Oct 2024 |
| Z-0087-2025 | Leica Biosystems Cryostat Model Number CM1850, Material Numbers: a) 14047131148, b) 14901850001, c) 14901850001R0501, d) 1491850UVUL; for freezing and sectioning tissue samples | 322 units | Class II | Ongoing | 23 Oct 2024 |
| Z-0088-2025 | Leica Biosystems Cryostat Model Number CM1900, Material Numbers: a) 14045227382, b) 14901900100, c) 14901900700, d) 1491900UVU2; for freezing and sectioning tissue samples | 25 units | Class II | Ongoing | 23 Oct 2024 |
| Z-0089-2025 | Leica Biosystems Cryostat Model Number CM1950, Material Numbers: a) 14047742467, b) 1491950C1US, c) 1491950C2US, d) 1491950C3US; for freezing and sectioning tissue samples | 30 units | Class II | Ongoing | 23 Oct 2024 |
| Z-0090-2025 | Leica Biosystems Cryostat Model Number CM3050 S, Material Numbers: a) 14047033518, b) 14903050S01, c) 14903050S02, d) 14903050S03; for freezing and sectioning tissue samples | 187 units | Class II | Ongoing | 23 Oct 2024 |
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.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class II: The middle of the three FDA recall classes.
The event in context
- Device events that started in 2024
- 970
- Share of these events in Class II
- 87%
- Product records in this event
- 6Median of the firm: 1
- Events of the firm on the register
- 5
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 Jan 2025 | Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware | Device | Class II | 1 |
| 10 May 2024 | Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station. | Device | Class II | 1 |
| 10 Apr 2024 | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | Device | Class II | 1 |
| 20 Nov 2023 | Leica HistoCore PEGASUS (PROCESSOR, TISSUE, AUTOMATED) | Device | Class II | 1 |
Official channels
- FDA enforcement report Z-0085-2025The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 95323. https://recallregister.com/fda/ii/95323/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
US Nationwide distribution.
- What quantity of product is in FDA event 95323?
- The event has 6 product records. The first record gives this quantity:
1 unit
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2024 have the same class?
- 87% of the 970 device events that started in 2024 are in Class II.