Leica Microsystems, Inc.
Complete recall history across all FDA and CPSC categories — 40 total recalls
Leica Microsystems, Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (40)
FDA medical device enforcement actions by Leica Microsystems, Inc.
| Date | Product | Reason | Class |
|---|---|---|---|
| Nov 21, 2022 | Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming... | Class II |
| Nov 21, 2022 | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standa... | There is a potential issue resulting in the Power Supply potentially becoming... | Class II |
| Nov 21, 2022 | Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system | There is a potential issue resulting in the Power Supply potentially becoming... | Class II |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. ... | During internal testing, Leica Microsystems has become aware of a component c... | Class II |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | During internal testing, Leica Microsystems has become aware of a component c... | Class II |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | During internal testing, Leica Microsystems has become aware of a component c... | Class II |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | During internal testing, Leica Microsystems has become aware of a component c... | Class II |
| Nov 3, 2021 | Leica Microsystems M220 F12 Microscope Systems | In May 2021, Leica Microsystems received one (1) complaint pertaining to the ... | Class II |
| Jul 30, 2021 | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 | Product may not perform as specified in IFU. | Class II |
| May 20, 2020 | Leica ARveo and M530 OH6 microscope systems. | Possible unintended interruption of surgical procedures due to equipment shut... | Class II |
| Nov 18, 2019 | BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system... | BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated sto... | Class II |
| May 3, 2019 | Leica Cryostats, used to produce frozen sample sections for biological, medic... | The current labelling does not include any specific warning about usage of fl... | Class II |
| Jan 2, 2019 | Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope... | The M220 optics may unintentionally drop into the surgical field, risking con... | Class II |
| Sep 17, 2018 | BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with... | The power supply unit for the printer used with the device can potentially ov... | Class II |
| Sep 4, 2018 | Leica M525 F20 Surgical Microscope System | The firm received complaints that the instrument tipped over when the swing a... | Class II |
| Sep 4, 2018 | Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological ... | Product was assembled with an isolating fiberglass hose within the oven in th... | Class II |
| Jun 25, 2018 | Leica M530 OHX Microscope System Supplied with 100 - 120 Vac. | Recall is due to a design weakness of the power insert module. | Class II |
| Jun 13, 2018 | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Us... | These devices have an incorrect specification against safety standard ISO6101... | Class II |
| Jun 4, 2018 | Leica Microsystems products labeled as the following: Leica M320 Microscope S... | Possible failure of screws which hold the gas spring fixation bracket in plac... | Class II |
| Sep 25, 2017 | PROVEO 8 Ophthalmic Microscope System optical instrument for improving the v... | The observed issues can lead to unexpected interruptions of the optics carrie... | Class II |
| Jun 19, 2017 | Nussloch GmbH ASP6025 Tissue Processor | Incorrect labeling for specified voltage for the Alarm Connectors on the rear... | Class II |
| Apr 5, 2016 | Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) ... | Testing of retained units indicated that Lot numbers of CDX2 and RCC indicate... | Class II |
| Apr 5, 2016 | Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the... | Testing of retained units indicated that Lot numbers of CDX2 indicated are no... | Class II |
| Mar 22, 2016 | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. ... | Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combinati... | Class II |
| Jan 11, 2016 | Leica Microsystems (Schweiz) Ag. The common name of the device is surgical mi... | An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical mic... | Class II |
| Dec 30, 2015 | This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody ... | The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may... | Class II |
| Nov 27, 2015 | Bond Polymer Refine Red Detection DS9390 kits. The common name of the device ... | The Firm informed the importer/distributor, Leica Microsystems, a manufactur... | Class II |
| Sep 3, 2015 | Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochem... | These Lot numbers are not stable up to the expiry date on the product labeling. | Class II |
| Aug 5, 2015 | The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departme... | The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring ... | Class III |
| Jul 27, 2015 | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. ... | The ASP6025 Tissue Processor instrument is incorrectly getting into a state o... | Class II |
| Dec 16, 2014 | Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunoh... | The staining intensity decreases over the shelf life. | Class II |
| Apr 18, 2014 | Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t... | Bond Ready to Use Primary Antibody Thyroglobulin does not function as intende... | Class II |
| Feb 26, 2014 | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Pr... | Class II |
| Jan 10, 2014 | Liquid Mouse Monoclonal Antibody CD15 (NCL-L-CD15), a liquid tissue culture s... | Product does not function as intended up to the expiry date on the product la... | Class II |
| Sep 11, 2013 | Leica Ceiling Mount MS-1F & MC-1F for use with the M500 N operating microscop... | The ceiling mount supplier encountered an event in which the drive screw in t... | Class II |
| Sep 11, 2013 | Leica Ceiling Mount MSF-1 for use with M841 and M501 operating microscopes. ... | The ceiling mount supplier encountered an event in which the drive screw in t... | Class II |
| Apr 4, 2013 | LPC Fine Mesh Cassette for the Leica LPC Printer. Part No: 14060546848; 14060... | An LPC Fine Mesh Cassette failed to stay closed during processing operations. | Class II |
| Nov 14, 2012 | Novocastra Ready-to-Use Mouse Monoclonal Antibody Terminal Deoxynuceotidyl Tr... | RTU-TdT-339 is not stable up to the expiry date on the product labeling, affe... | Class II |
| Nov 13, 2012 | Leica ASP6025 Vacuum Tissue Processor The Leica ASP6025 is a modular tissu... | The Instruction for Use 1v9 Ref F and all previous versions specify incorrect... | Class II |
| Jun 4, 2012 | Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems... | Leica Microsystems evaluated data showing that a malfunction resulting in an ... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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