Buffalo Grove, IL, United States
Leica Microsystems, Inc. recalls
15 recalls recorded since 2018, most recently on 21 November 2022. 3 are listed as ongoing. Status and classification are as published by the FDA.
Recalls15
Ongoing (FDA)3
Terminated or completed12
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 21 November 2022
- Reason
- There is a potential issue resulting in the Power Supply potentially becoming overheated due to internal components overstressing. Consequently, due to the overstressing of the internal components, one specific component can fail which will cause the device to unexpectedly shutdown.
- Distribution
- US Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0477-2023, Z-0476-2023, Z-0475-2023
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
- Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
- Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Ongoing Class II Medical devices
- Recall started
- 26 August 2022
- Reason
- During internal testing, Leica Microsystems has become aware of a component change on the photodiodes inside the M530 Optics Carrier which will result in an inaccurate adjustment of the illumination limits by the software of the surgical microscope when "BrightCare Plus" with Luxmeter is used.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1850-2022, Z-1848-2022, Z-1849-2022, Z-1851-2022
- Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
- Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
- Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
- Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Terminated Class II Medical devices
- Recall started
- 3 November 2021
- Terminated
- 18 June 2024
- Reason
- In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some potential injury risk. In the event that this defect may occur, the M220 optics carrier may unintentionally drop into the surgical field, risking contact with the patient.
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of CA, DC, FL, GA, IL, IN, MA, MI, MD, NY, OH, OR, PA, TN, TX, VA, WI, and Puerto Rico. The countries of Albania, Algeria, Argentina, Armenia, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Burundi, Canada, Chile, China, C
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0412-2022
- Leica Microsystems M220 F12 Microscope Systems
Terminated Class II Medical devices
- Recall started
- 30 July 2021
- Terminated
- 22 June 2023
- Reason
- Product may not perform as specified in IFU.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2481-2021
- BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Terminated Class II Medical devices
- Recall started
- 20 May 2020
- Terminated
- 13 May 2021
- Reason
- Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
- Distribution
- Domestic distribution: AL,AR,AZ, CA, CT, DC, DE, FL, IL, KY, LA, MI, MN, MO, NC, NY, OH. OR. TN, TX, UT, VA, WA, WI ,WV. International distribution: Japan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2399-2020
- Leica ARveo and M530 OH6 microscope systems.
Ongoing Class II Medical devices
- Recall started
- 18 November 2019
- Reason
- BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
- Distribution
- Nationwide and OUS to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0673-2020
- 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 conjug
Terminated Class II Medical devices
- Recall started
- 3 May 2019
- Terminated
- 28 September 2023
- Reason
- The current labelling does not include any specific warning about usage of flammable freezing sprays. Such flammable freezing sprays can potentially ignite and can cause serious injuries.
- Distribution
- Distributed to Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District Of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska,
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1729-2019
- Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
Terminated Class II Medical devices
- Recall started
- 2 January 2019
- Terminated
- 2 April 2021
- Reason
- The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
- Distribution
- Worldwide distribution: US (nationwide) and countries of: Albania, Algeria, Armenia, Argentina, Bangladesh, Brazil, Burundi, Canada, China, Colombia, Egypt, France, Germany, Guatemala, India, Indonesia, Japan, Nepal, Netherlands, New Zealand, Malaysia, Pakistan, Peru, Philippines, Poland, Qatar, R
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0772-2019
- 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
Terminated Class II Medical devices
- Recall started
- 17 September 2018
- Terminated
- 21 August 2020
- Reason
- The power supply unit for the printer used with the device can potentially overheat or cause a fire hazard because it could contain an improperly-mixed phosphorus compound.
- Distribution
- Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0281-2019
- BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 10 July 2020
- Reason
- Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
- Distribution
- Distribution in US state of MO.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0019-2019
- Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
Terminated Class II Medical devices
- Recall started
- 4 September 2018
- Terminated
- 17 August 2021
- Reason
- The firm received complaints that the instrument tipped over when the swing arm was fully extended.
- Distribution
- US and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3175-2018
- Leica M525 F20 Surgical Microscope System
Terminated Class II Medical devices
- Recall started
- 25 June 2018
- Terminated
- 26 February 2019
- Reason
- Recall is due to a design weakness of the power insert module.
- Distribution
- United States distribution: AR, AZ, CA, CO, CT, DE, FL, IL, IN, KS, KY, LA, MO, NJ, NY, NV, OH, OR, PA, TX, UT, PR. International distribution to Japan, Brazil, Columbia, Ecuador, Mexico, Taiwan
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2659-2018
- Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Terminated Class II Medical devices
- Recall started
- 13 June 2018
- Terminated
- 18 March 2019
- Reason
- These devices have an incorrect specification against safety standard ISO61010-1. Should a single fault error occur, a mains wire can contact a metal plate which is accessible to the user. This could lead to mains power on the metal plate resulting in hazardous voltage to the user.
- Distribution
- Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0064-2019
- 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
Terminated Class II Medical devices
- Recall started
- 4 June 2018
- Terminated
- 25 March 2021
- Reason
- Possible failure of screws which hold the gas spring fixation bracket in place. Due to this failure, the gas spring, which is fixed to the upper part of the parallelogram, cannot hold up the weight of the optics carrier.
- Distribution
- Worldwide Distribution US Nationwide in the states of : CA, CO, CT, FL, HI, ID, IL, KS, KY, LA, MD, MI, MN, MO, NC, NJ, NY, OH, PA, SD, TN, TX. International Distribution: Canada, AUSTRALIA, BELGIUM, Bolivia, BRAZIL, BULGARIA, CHILE, CHINA, DENMARK, EGYPT, EL SALVADOR, FINLAND, FRANCE, GERMA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2555-2018
- 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
Terminated Class II Medical devices
- Recall started
- 25 September 2017
- Terminated
- 21 January 2020
- Reason
- The observed issues can lead to unexpected interruptions of the optics carrier focus drive movement, intermittent stops of the X-Y coupling movement or sporadic failures in the proper on-screen display functionality of the HDR recording unit. Additionally, an anomaly in the device software may also lead to the unexpected behavior that when a user releases a handle or foot switch button this may not immediately end the actuated functionality. This behavior can only occur in unlikely workflows where a user changes a user profile or a mode change is initiated at the same time as a functional button is activated.
- Distribution
- Worldwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0838-2019
- 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 m
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.