PlainRecalls

Leica Microsystems, Inc.

22 recalls on record · Latest: Dec 21, 2022

Leica Microsystems, Inc. Recall Insight

Leica Microsystems, Inc. appears on 22 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.026% 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 22 entries, severity tagging shows 0 critical, 22 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 22 of 22 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 (22). 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 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 Sep 22, 2021

BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375

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 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 Aug 15, 2018

Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.

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 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 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 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 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…

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Data Sources

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