Leica Microsystems, Inc.
40 recalls on record · Latest: Dec 21, 2022
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Agency notice ledger
Federal filing book Leica Microsystems, Inc. MID-BOOK · SINGLE-AGENCY
#430 of 14,151 · 40 notices · 0.038% archive
- BOOK 40 notices
- RANK #430 of 14,151
- SHARE 0.038% archive
- AGENCY FDA Devices (40)
- CAT medical devices
- CATS 1 category
- LATEST Dec 21, 2022
- PHOTO 3M Company
Nearest notice-volume peer: 3M Company - Health Care Business (0 notice gap)
Leica Microsystems, Inc. accounts for about 0.038% of the 104,423-notice archive on 40 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →
How Leica Microsystems, Inc. compares to 14,151 recalling firms
Leica Microsystems, Inc. ranks 430th of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.
Leica Microsystems, Inc. vs all firms by recall-notice count
Where this firm's archive sits among every tracked recalling manufacturer
40 430th of 14151 higher than 13,719 of 14,151 firms
Firms, banded by distinct federal recall-event inventory
Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-13
Leica Microsystems, Inc. in the notice-volume neighbourhood
Distinct federal recall events among this firm and nearest nationwide peers
- Leica Microsy… (this)
Leica Microsystems, Inc.
40 notices
- 3M Company
3M Company - Health Care Business
40 notices
- Aesculap Inc
Aesculap Inc
40 notices
- Alcon Researc…
Alcon Research, LTD.
40 notices
- Gh Foods Ca L…
Gh Foods Ca LLC
40 notices
- Hp Hood LLC
Hp Hood LLC
40 notices
What this shows Leica Microsystems, Inc. holds about 0.038% of archive notices alongside 40 distinct filings.
FDA Devices Moderate Dec 21, 2022
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA Devices Moderate Dec 21, 2022
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
FDA Devices Moderate Dec 21, 2022
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
FDA Devices Moderate Oct 5, 2022
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA Devices Moderate Oct 5, 2022
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA Devices Moderate Oct 5, 2022
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA Devices Moderate Oct 5, 2022
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA Devices Moderate Dec 29, 2021
Leica Microsystems M220 F12 Microscope Systems
FDA Devices Moderate Sep 22, 2021
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
FDA Devices Moderate Jun 24, 2020
Leica ARveo and M530 OH6 microscope systems.
FDA Devices Moderate Dec 18, 2019
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond Polymer Refine Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
FDA Devices Moderate Jun 12, 2019
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
FDA Devices Moderate Feb 27, 2019
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Devices Moderate Jan 30, 2019
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
FDA Devices Moderate Nov 7, 2018
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
FDA Devices Moderate Oct 10, 2018
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
FDA Devices Moderate Oct 10, 2018
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a stainer for laboratory applications and intended for the preparation of histological and cytological specimens.
FDA Devices Moderate Sep 26, 2018
Leica M525 F20 Surgical Microscope System
FDA Devices Moderate Aug 15, 2018
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
FDA Devices Moderate Aug 1, 2018
Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419, 10448420, 10448485, 10448486 Product Usage: Intended use of this device is an optical instrument for magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.
FDA Devices Moderate Jul 12, 2017
Nussloch GmbH ASP6025 Tissue Processor
FDA Devices Moderate Jun 8, 2016
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
FDA Devices Moderate Jun 8, 2016
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
FDA Devices Moderate Jun 1, 2016
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
FDA Devices Moderate Apr 27, 2016
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned the product code FSO by the FDA and is classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
FDA Devices Moderate Mar 2, 2016
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Devices Moderate Feb 24, 2016
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
FDA Devices Moderate Dec 2, 2015
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
FDA Devices Moderate Sep 30, 2015
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
FDA Devices Low Sep 23, 2015
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
FDA Devices Moderate Apr 1, 2015
Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunohistochemical (IHC) staining. Product Usage: NCL-L-CD15 is intended for the qualitative identification by light microscopy of CD15 molecules in paraffin sections. The clinical interpretation of any staining or its absence should be complemented by morphological studies using proper controls and should be evaluated within the context of the patients clinical history and other diagnostic tests by a qualified pathologis
FDA Devices Moderate Nov 12, 2014
Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a tissue culture supernatant, and supplied in Tris buffered saline with carrier protein, containing 0.35% ProClin 950 as a preservative. Total volume = 7 mL. This reagent is for in vitro diagnostic use. Thyroglobulin (1D4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of thyroglobulin in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using an
FDA Devices Moderate Jun 18, 2014
Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. Article Number 10446781 utilizes a supply voltage of 230 V. Article Number 10446782 utilizes a supply voltage of 110 V. Intended to be used for improving the visibility of objects through magnification and illumination.
FDA Devices Moderate Jun 18, 2014
Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscope. Article Number 10446657 utilizes a supply voltage of 110 V. Article Number 10446658 utilizes a supply voltage of 220 V. Intended to be used for improving the visibility of objects through magnification and illumination.
FDA Devices Moderate Jun 11, 2014
Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL-L-GSTpi-438), a liquid tissue culture supernatant. For in vitro diagnostic use.
FDA Devices Moderate Jun 11, 2014
Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture supernatant containing 15 mM sodium azide as a preservative. For in vitro diagnostic use.
FDA Devices Moderate Aug 7, 2013
Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissue processor for the following laboratory applications: fixation, dehydration, infiltration with intermedium, and the paraffin infiltration of histological tissue specimens.
FDA Devices Moderate Jun 12, 2013
LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850; 14060546847. The intended use of this device is for storage of specimens/tissues during processing.
FDA Devices Moderate Dec 19, 2012
Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Transferase Staining Reagent; an in vitro staining reagent for the qualitative identification by light microscopy of Terminal Deoxynucleotidyl Transferase molecules in paraffin sections; Catalog No. RTU-TdT-339; packaged in 7 mL vials; Leica Biosystems Newcastle Ltd., Balliol Business Park West, Benton Lane, Newcastle Upon Tyne NE12 8EW, United Kingdom. RTU-TdT-339 is intended for the qualitative identification by lig
FDA Devices Moderate Aug 1, 2012
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland Product Usage: The intended use of this device is for improving visibility of objects through magnification and illumination. It can be applied for observation and documentation and for human and veterinary medical treatment.
Leica Microsystems, Inc. holds a measurable archive slice
Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.
Similar recall count
Nearest multi-notice firms by distinct-event totals (40 here — heavy-book).
Similar medical devices volume
Nearest multi-notice firms in the same narrow category lane.
Frequently Asked Questions
How many federal recall notices name Leica Microsystems, Inc.? ▼
PlainRecalls indexes 40 distinct federal recall events naming Leica Microsystems, Inc., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Leica Microsystems, Inc. sit among other recalling firms? ▼
Leica Microsystems, Inc. ranks #430 of 14,151 by distinct recall-event count among 14,151 firms in this archive (97th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Leica Microsystems, Inc.'s notices? ▼
FDA Devices accounts for 40 of this firm's 40 indexed notices.
What product category dominates Leica Microsystems, Inc.'s filing book? ▼
Filings for Leica Microsystems, Inc. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Leica Microsystems, Inc.: 40 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.
Firm-level totals aggregate distinct federal recall events naming Leica Microsystems, Inc.; individual notices remain authoritative on each linked recall page.
Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026