Leica Microsystems, Inc.

Also registered as Leica Microsystems, Inc. O.I.D.

United StatesFDA applicant, unverified

Devices: 3
FDA recalls: 607 ongoing since 2021 (9 open in total); 2 open since before 2021

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Leica Microsystems, Inc. makes

Leica Microsystems, Inc. manufactures fluorescence microscopes, including the LEICA MODEL FL800 and the LEICA AT550, designed for advanced biological and medical imaging applications.

These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

Portable Non-Contact Tonometer, Model PT100 Ref K013259

Active Regimes: 510(k) Registry: 510(k) Class:II
Leica Model FL800 Ref K061871

Active Regimes: 510(k) Registry: 510(k) Class:II
Leica AT550 Ref K990869

Active Regimes: 510(k) Registry: 510(k) Class:II

FDA recalls60

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 60 recalls initiated by Leica Microsystems, Inc., the earliest on 2005-04-12 and the most recent on 2022-11-21. By recorded status: 9 ongoing and 51 terminated. The reasons filed fall into these groups: labeling or instructions for use, software or firmware, electrical or power, mechanical integrity, performance or accuracy and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 2
2018 6
2019 3
2020 1
2021 2
2022 7
2023 0
2024 0
2025 0
2026 0

39 initiated before 2017

Showing the 10 most recent of 60 recalls.

2022
- 21 Nov 2022 Z-0475-2023 Class II Ongoing 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
- 21 Nov 2022 Z-0476-2023 Class II Ongoing 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
- 21 Nov 2022 Z-0477-2023 Class II Ongoing 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
- 26 Aug 2022 Z-1848-2022 Class II Ongoing 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.
- 26 Aug 2022 Z-1849-2022 Class II Ongoing 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.
- 26 Aug 2022 Z-1850-2022 Class II Ongoing 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.
- 26 Aug 2022 Z-1851-2022 Class II Ongoing 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.
2021
- 3 Nov 2021 Z-0412-2022 Class II Terminated 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,…
  Full distribution text
  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, Colombia, Congo, Costa Rica, Dominican Republic, Ecuador, Egypt, France, Germany, Georgia, Great Britain, Greece, Hong Kong, India, Indonesia, Iraq, Ireland, Italy, Japan, South Korea, Kuwait, Latvia, Lebanon, Libya, Malaysia, Mexico, Morocco, Myanmar, Netherlands, New Zealand, Nicaragua, Nigeria, Norway, Pakistan, Palestine, Peru, Philippines, Poland, Portugal, North Macedonia, Romania, Russia, Saudi Arabia, Senegal, Serbia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, Uruguay, Vietnam.
- 30 Jul 2021 Z-2481-2021 Class II Terminated Product may not perform as specified in IFU. Distribution: US Nationwide distribution.
2020
- 20 May 2020 Z-2399-2020 Class II Terminated 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.…
  Full distribution text
  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

Show the 25 most recent of 60 recalls

2019
- 18 Nov 2019 Z-0673-2020 Class II Open since 2019 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.
- 3 May 2019 Z-1729-2019 Class II Terminated 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,…
  Full distribution text
  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, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin, Wyoming. Distributed internationally to Canada.
- 2 Jan 2019 Z-0772-2019 Class II Terminated 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,…
  Full distribution text
  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, Romania, Russia Federation, Saudi Arabia, Senegal, Spain, South Africa, South Korea, Switzerland, Tanzania, Thailand, Turkey, Ukraine, and Vietnam.
2018
- 17 Sep 2018 Z-0281-2019 Class II Terminated 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.
- 4 Sep 2018 Z-0019-2019 Class II Terminated 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.
- 4 Sep 2018 Z-3175-2018 Class II Terminated The firm received complaints that the instrument tipped over when the swing arm was fully extended. Distribution: US and Canada
- 25 Jun 2018 Z-2659-2018 Class II Terminated 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.…
  Full distribution text
  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
- 13 Jun 2018 Z-0064-2019 Class II Terminated 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…
  Full distribution text
  Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND
- 4 Jun 2018 Z-2555-2018 Class II Terminated 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,…
  Full distribution text
  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, GERMANY, HONGKONG, HUNGARY, INDIA, ISRAEL, ITALY, JAPAN, KUWAIT, MALAYSIA, PHILIPPINES, POLAND, PORTUGAL, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, TAIWAN,THAILAND, TURKEY, UK
2017
- 25 Sep 2017 Z-0838-2019 Class II Terminated 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
- 19 Jun 2017 Z-2660-2017 Class II Open since 2017 Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit. Distribution: Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA,…
  Full distribution text
  Domestic: AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH, PA, SC, TN, TX, UT, VA, WA, WI, WV, & DC. Foreign: Australia, Austria, Bangladesh, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Czech Republic, England, France, Georgia, Germany, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Lithuania, Malaysia, Maldives, Mexico, Morocco, Myanmar, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, & United Arab Emirates.
2016
- 5 Apr 2016 Z-1876-2016 Class II Terminated Testing of retained units indicated that Lot numbers of CDX2 and RCC indicated are not stable up to the expiry date on the product labeling. Distribution: Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
- 5 Apr 2016 Z-1877-2016 Class II Terminated Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling. Distribution: Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
- 22 Mar 2016 Z-1704-2016 Class II Terminated Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining. Distribution: Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of…
  Full distribution text
  Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
- 11 Jan 2016 Z-1499-2016 Class II Terminated An electronic component of the Leica M525 OH4 and Leica M720 OH5 surgical microscopes with 400W illumination could potentially overheat, resulting in smoke and smell emanating from the ventilation openings of the illumination units located opposite and away from the surgeon / patient side of the surgical microscope. Distribution: Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO,…
  Full distribution text
  Worldwide Distribution-US (nationwide) including Puerto Rico and the states of MA, CA, SC, NJ, TX, CO, FL, PA, NY, MO, WI, NC, UT, ID, AZ, MI, KY, CT, OR, , IL, AL, MN, MT, OH, NE, GA, IN, SD, TN, OK, AK, KS, NV, NM, , ND, VA, WA, WY and MD, and the countries of China, Belgium, France, Germany, Great Britain, Italy, Norway, Portugal, Spain, Sweden, Switzerland, India, Japan, Argentina, Chile, Colombia, Mexico, Peru, Belarus, Egypt, Greece, Morocco, Poland, Qatar, Romania, Russian Fed., Saudi Arabia, South Africa, Turkey, Canada, , Australia, Malaysia and Taiwan.

Frequently asked questions

How many devices does Leica Microsystems, Inc. have in the registry?

The registry currently lists 3 devices for Leica Microsystems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Leica Microsystems, Inc.'s devices?

Among its 3 most recently registered devices, Leica Microsystems, Inc. has devices listed in FDA 510(k) (3 devices).

What risk classes do Leica Microsystems, Inc.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for Leica Microsystems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Leica Microsystems, Inc.?

FDA recall records list 60 recalls initiated by Leica Microsystems, Inc., the most recent initiated on 21 Nov 2022. 9 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Leica Microsystems, Inc. in the registry?

The most recently registered devices listed for Leica Microsystems, Inc. include PORTABLE NON-CONTACT TONOMETER, MODEL PT100, LEICA MODEL FL800 and LEICA AT550.

Generated automatically from registry data and not verified by a human reviewer.