Browse Device Recalls
40 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 40 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 40 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 overheated due to i... | Class II | Leica Microsystems, Inc. |
| Nov 21, 2022 | Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standa... | There is a potential issue resulting in the Power Supply potentially becoming overheated due to i... | Class II | Leica Microsystems, Inc. |
| 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 overheated due to i... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. ... | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, Arveo, Part Number 10448999 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Aug 26, 2022 | Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737 | During internal testing, Leica Microsystems has become aware of a component change on the photodi... | Class II | Leica Microsystems, Inc. |
| Nov 3, 2021 | Leica Microsystems M220 F12 Microscope Systems | In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Mi... | Class II | Leica Microsystems, Inc. |
| Jul 30, 2021 | BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375 | Product may not perform as specified in IFU. | Class II | Leica Microsystems, Inc. |
| May 20, 2020 | Leica ARveo and M530 OH6 microscope systems. | Possible unintended interruption of surgical procedures due to equipment shutdown, related to cha... | Class II | Leica Microsystems, Inc. |
| 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 storage longer than spe... | Class II | Leica Microsystems, Inc. |
| 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 flammable freezing spr... | Class II | Leica Microsystems, Inc. |
| 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 contact with the patient. | Class II | Leica Microsystems, Inc. |
| 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 overheat or cause a fi... | Class II | Leica Microsystems, Inc. |
| Sep 4, 2018 | Leica M525 F20 Surgical Microscope System | The firm received complaints that the instrument tipped over when the swing arm was fully extended. | Class II | Leica Microsystems, Inc. |
| 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 the wrong position. Th... | Class II | Leica Microsystems, Inc. |
| 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 | Leica Microsystems, Inc. |
| Jun 13, 2018 | Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Us... | These devices have an incorrect specification against safety standard ISO61010-1. Should a single... | Class II | Leica Microsystems, Inc. |
| 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 place. Due to this fail... | Class II | Leica Microsystems, Inc. |
| 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 carrier focus drive moveme... | Class II | Leica Microsystems, Inc. |
| Jun 19, 2017 | Nussloch GmbH ASP6025 Tissue Processor | Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. | Class II | Leica Microsystems, Inc. |
| 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 indicated are not stable up ... | Class II | Leica Microsystems, Inc. |
| 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 not stable up to the e... | Class II | Leica Microsystems, Inc. |
| Mar 22, 2016 | Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. ... | Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lot... | Class II | Leica Microsystems, Inc. |
| 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 microscopes with 400W i... | Class II | Leica Microsystems, Inc. |
| 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 not provide adequat... | Class II | Leica Microsystems, Inc. |
| 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 manufacturing error occurred d... | Class II | Leica Microsystems, Inc. |
| 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 | Leica Microsystems, Inc. |
| Aug 5, 2015 | The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departme... | The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm ... | Class III | Leica Microsystems, Inc. |
| Jul 27, 2015 | The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. ... | The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty du... | Class II | Leica Microsystems, Inc. |
| Dec 16, 2014 | Liquid Mouse Monoclonal Antibody CD15 used is laboratories to perform immunoh... | The staining intensity decreases over the shelf life. | Class II | Leica Microsystems, Inc. |
| 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 intended up to the expiry d... | Class II | Leica Microsystems, Inc. |
| Feb 26, 2014 | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (NCL... | Novocastra Liquid Mouse Monoclonal Antibody Glutathione S-Transferase pi (Product Code: NCL-L-GS... | Class II | Leica Microsystems, Inc. |
| 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 labeling. There is a ... | Class II | Leica Microsystems, Inc. |
| 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 the motor unit, which... | Class II | Leica Microsystems, Inc. |
| 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 the motor unit, which... | Class II | Leica Microsystems, Inc. |
| 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 | Leica Microsystems, Inc. |
| 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, affecting the staining i... | Class II | Leica Microsystems, Inc. |
| 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 dimensions for the ... | Class II | Leica Microsystems, Inc. |
| Jun 4, 2012 | Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems... | Leica Microsystems evaluated data showing that a malfunction resulting in an illumination reducti... | Class II | Leica Microsystems, Inc. |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.