PlainRecalls

Leica Microsystems, Inc.

Compiled from official public sources by the editorial team.

40 recalls on record · Latest: Dec 21, 2022

Leica Microsystems, Inc. Recall Insight

Leica Microsystems, Inc. appears on 40 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.039% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Dec 21, 2022, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 40 entries, severity tagging shows 0 critical, 39 moderate, and 1 lower-severity recalls. Affected-unit counts are disclosed on 40 of 40 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (40). The date window on this page runs from Aug 1, 2012 to Dec 21, 2022.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

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 bio…

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) appl…

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 a…

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 throug…

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 diag…

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 applic…

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 Pr…

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 definitio…

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…

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 cl…

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 micro…

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 stat…

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 a…

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 proces…

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 …

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 fo…

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 car…

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 Numb…

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 N…

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 diagn…

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 vitr…

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, dehydra…

FDA Devices Moderate Jun 12, 2013

LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060546846; 14060546845; 14060546933; 14060546932; 14060546852; 14060546850;…

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 qualita…

FDA Devices Moderate Aug 1, 2012

Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max Schmidheiny Strasse, Heerbrugg, Switzerland P…

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

Compare Leica Microsystems, Inc. with Zimmer Biomet, Inc. →

Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.