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Leica Microsystems, Inc.
Leica Microsystems, Inc.: 40 FDA recall reports
Every medical device recall the FDA has published for Leica Microsystems, Inc.. The fault, and how the agency graded it.
40Reports
0Class I
9Ongoing
2022-12-21Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Z-0477-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
- Where it went
- US Nationwide
- How much
- 148 units
Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope syste
Z-0476-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
- Where it went
- US Nationwide
- How much
- 38 units
Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
Z-0475-2023 · Class II · reported 2022-12-21 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
- Where it went
- US Nationwide
- How much
- 43 units
Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Z-1850-2022 · Class II · reported 2022-10-05 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
- Where it went
- US Nationwide distribution.
- How much
- 115 devices
Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
Z-1848-2022 · Class II · reported 2022-10-05 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
- Where it went
- US Nationwide distribution.
- How much
- 30 devices
Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
Z-1849-2022 · Class II · reported 2022-10-05 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
- Where it went
- US Nationwide distribution.
- How much
- 25 devices
Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
Z-1851-2022 · Class II · reported 2022-10-05 · Ongoing
- Why it was recalled
- 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.
- Product
- Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
- Where it went
- US Nationwide distribution.
- How much
- 32 devices
Leica Microsystems M220 F12 Microscope Systems
Z-0412-2022 · Class II · reported 2021-12-29 · Terminated
- Why it was recalled
- 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.
- Product
- Leica Microsystems M220 F12 Microscope Systems
- Where it went
- 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.
- How much
- 2,800
BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Z-2481-2021 · Class II · reported 2021-09-22 · Terminated
- Why it was recalled
- Product may not perform as specified in IFU.
- Product
- BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
- Where it went
- US Nationwide distribution.
- How much
- 237 units
Leica ARveo and M530 OH6 microscope systems.
Z-2399-2020 · Class II · reported 2020-06-24 · Terminated
- Why it was recalled
- Possible unintended interruption of surgical procedures due to equipment shutdown, related to changes in voltage.
- Product
- Leica ARveo and M530 OH6 microscope systems.
- Where it went
- 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
- How much
- Domestic distribution 65 devices. International distribution 12 devices. Total of devices distributed 77.
BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use.
Z-0673-2020 · Class II · reported 2019-12-18 · Ongoing
- Why it was recalled
- BOND Polymer Refine Detection kits (DS9800) were held out of refrigerated storage longer than specified which may exhibit suboptimal staining.
- Product
- 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 conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
- Where it went
- Nationwide and OUS to Canada.
- How much
- 558
Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, i
Z-1729-2019 · Class II · reported 2019-06-12 · Terminated
- Why it was recalled
- 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.
- Product
- Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
- Where it went
- 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.
- How much
- 17,179 devices total (4,835 US, 12,344 OUS)
PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magn
Z-0838-2019 · Class II · reported 2019-02-27 · Terminated
- Why it was recalled
- 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.
- Product
- 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 medical treatment.
- Where it went
- Worldwide
- How much
- 142 units
Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for imp
Z-0772-2019 · Class II · reported 2019-01-30 · Terminated
- Why it was recalled
- The M220 optics may unintentionally drop into the surgical field, risking contact with the patient.
- Product
- 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 documentation and for human and veterinary medical treatment.
- Where it went
- 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.
- How much
- 15 units
BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instrument
Z-0281-2019 · Class II · reported 2018-11-07 · Terminated
- Why it was recalled
- 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.
- Product
- BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
- Where it went
- Distribution was nationwide. There was also government/military distribution. Foreign distribution was made to Canada.
- How much
- 876 devices (in U.S. and Canada)
Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples fo
Z-0019-2019 · Class II · reported 2018-10-10 · Terminated
- Why it was recalled
- Product was assembled with an isolating fiberglass hose within the oven in the wrong position. This results in improper shielding from potential electrical shock.
- Product
- Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
- Where it went
- Distribution in US state of MO.
- How much
- 1 unit
Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this de
Z-0064-2019 · Class II · reported 2018-10-10 · Terminated
- Why it was recalled
- 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.
- Product
- 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 specimens.
- Where it went
- Distributed nationwide to AZ, CA, CO, KS, MA, MH, MO, NJ, OH, WI. Distributed worldwide to CANADA, CHINA, GERMANY, GREAT BRITAIN, JAPAN, SWITZERLAND
- How much
- 67 units
Leica M525 F20 Surgical Microscope System
Z-3175-2018 · Class II · reported 2018-09-26 · Terminated
- Why it was recalled
- The firm received complaints that the instrument tipped over when the swing arm was fully extended.
- Product
- Leica M525 F20 Surgical Microscope System
- Where it went
- US and Canada
- How much
- 160 units
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Z-2659-2018 · Class II · reported 2018-08-15 · Terminated
- Why it was recalled
- Recall is due to a design weakness of the power insert module.
- Product
- Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
- Where it went
- 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
- How much
- 123 devices total
Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448
Z-2555-2018 · Class II · reported 2018-08-01 · Terminated
- Why it was recalled
- 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.
- Product
- 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 magnifying and illuminating specimens. It can be applied for observation and documentation and for human and veterinary medical treatment. Not for use in Eye Operations.
- Where it went
- 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
- How much
- 8,564 Total Units
Nussloch GmbH ASP6025 Tissue Processor
Z-2660-2017 · Class II · reported 2017-07-12 · Ongoing
- Why it was recalled
- Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.
- Product
- Nussloch GmbH ASP6025 Tissue Processor
- Where it went
- 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.
- How much
- 812 units
Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in no
Z-1877-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- Testing of retained units indicated that Lot numbers of CDX2 indicated are not stable up to the expiry date on the product labeling.
- Product
- Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
- Where it went
- Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
- How much
- 90 Units
Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of
Z-1876-2016 · Class II · reported 2016-06-08 · Terminated
- Why it was recalled
- 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.
- Product
- Novocastr Liquid Mouse Monoclonal Antibody Renal Cell Carcinoma Marker (RCC) is recommended for use as part of a panel of antibodies in the definition of tumors of proximal nephrogenic differentiation.
- Where it went
- Distributed in the following states AR, CA, CT, FL, ID, IL, IN, MT, OH, PA, TN and TX, and in Canada.
- How much
- 270 units
Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative iden
Z-1704-2016 · Class II · reported 2016-06-01 · Terminated
- Why it was recalled
- Novocastra Liquid Mouse Monoclonal Antibody Calretinin when used in combination with specific Lots of antibody diluent will give reduced staining.
- Product
- Novocastra Liquid Mouse Monoclonal Antibody Calretinin, NCL-L-CALRET-566. Intended for the qualitative identification by light microscopy of human calretinin molecule in paraffin sections.
- Where it went
- Worldwide Distribution -- U.S., to the following states: AK, CA, FL, GA, MN, MT, NJ, OH, TX and WA; and, the country of Canada.
- How much
- 290 units
Leica Microsystems (Schweiz) Ag. The common name of the device is surgical microscope. It has been assigned th
Z-1499-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- 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.
- Product
- 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 classified as a Class I medical device. Intended for improving the visibility of objects through magnification and illumination.
- Where it went
- 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.
- How much
- 381 units
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qu
Z-0823-2016 · Class II · reported 2016-03-02 · Terminated
- Why it was recalled
- The Bond" Polymer Refine Detection and Novolink" Polymer Detection System may not provide adequate staining when using a detection protocol where one of its components - Peroxide Block / Peroxidase Block is applied after the primary marker incubation as specified in the Instructions for Use Following the Instructions for Use.
- Product
- This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
- Where it went
- US Consignees incluude: AR ,AZ ,CA ,CO ,CT ,DC ,DE ,FL ,GA ,HI ,IA ,IL ,KY ,LA ,MA ,MD ,MI ,MN ,MO ,MT ,NC ,NH ,NJ ,NY ,OH ,OK ,PA ,PR ,SC ,TN ,TX ,UT ,VA ,VT ,WA ,WI and WV. Foreign Consignees include:Argentina , Australia , Brazil , Bulgaria , Chile , China , Ecuador ,Egypt , El Salvador , Finland , France , Georgia , Germany , Greece , India , Italy , Japan , Jordan , Kuwait , Lebanon , Malaysia , Philippines , Poland , Portugal , Romania , Russian Fed. , Singapore , South Korea , Spain , Sweden , Switzerland , Thailand , Tunisia , Turkey , United Kingdom and United Arab Emirates.
- How much
- 1700 units
Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro
Z-0808-2016 · Class II · reported 2016-02-24 · Terminated
- Why it was recalled
- The Firm informed the importer/distributor, Leica Microsystems, a manufacturing error occurred during the filling of some containers of the Bond Polymer Refine Red Detection DS9390 kits, which may result in inadequate staining.
- Product
- Bond Polymer Refine Red Detection DS9390 kits. The common name of the device is detection system for in vitro diagnostic use. The Intended Use states that Bond Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the detection of tissue-bound mouse and rabbit IgG and some mouse IgM primary antibodies. It is intended for staining sections of formalin-fixed, paraffin-embedded tissue on the BOND automated system.
- Where it went
- Worldwide Distribution - USA (nationwide) Distribution and to the countries of : Argentina, Australia, Austria, Belgium, Chile, Denmark, France, Germany, Greece, Hong Kong, Italy, Japan , Netherlands, Romania Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and UK.
- How much
- 3745
Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.
Z-0341-2016 · Class II · reported 2015-12-02 · Terminated
- Why it was recalled
- These Lot numbers are not stable up to the expiry date on the product labeling.
- Product
- Novocastra Lyophilized Mouse Monoclonal Antibody CD10 (CD10). Immunohistochemistry. in vitro diagnostic. 0.1ml NCL-CD10-270 and 1mL NCL-CD10-270 are intended for the qualitative identification by light microscopy of CD10 molecules in paraffin sections.
- Where it went
- Worldwide Distribution - US Nationwide, Australia, Austria, Brazil, Canada, China, Czech Republic, Finland, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Netherlands, Norway, Romania, Singapore, Slovenia, South Korea, Spain, Sweden, Switzerland and UK.
- How much
- U.S: 1 unit of CD10-270-CE-S & 66 units of CD10-270-CE. Foreign: 83 units of CD10-270-CE-S & 219 units of CD10-270-CE
The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processo
Z-2804-2015 · Class II · reported 2015-09-30 · Terminated
- Why it was recalled
- The ASP6025 Tissue Processor instrument is incorrectly getting into a state of bottle empty during retort filling, after passing the fill lever sensor 2 and prior to reaching level sensor 3, thus not completing a 5 litre fill.
- Product
- The Leica ASP6025 Tissue Processor. Pathology and Hematology Departments. The Leica ASP6025 Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
- Where it went
- Worldwide Distribution - US including AR, AZ, CA, CT, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NE, NJ, NM, NV, NY, OH,PA, SC, TN, TX, VA, WA, WI, WV and District of Columbia. Foreign distribution to United Arab Emirates, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Czech Republic , Germany, Spain, France, England, Georgia, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, Korea, Kuwait, Lithuania, Myanmar, Mexico, Malaysia, Netherland, Norway, Peru, Philippines, Poland, Qatar, Reunion, Romania, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Turkey, Taiwan, and South Africa.
- How much
- U.S. Quantity Distributed: 163 systems; Foreign Quantity Diistributed: 410 systems.
The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S T
Z-2779-2015 · Class III · reported 2015-09-23 · Terminated
- Why it was recalled
- The Leica ASP200S/ASP300S Tissue Processor have an incorrect internal wiring to the remote alarm plug, which can cause the remote alarm to not function correctly in the case of an instrument failure.
- Product
- The Leica ASP200S/ASP300S Tissue Processor. Pathology and Hematology Departments. The Leica ASP200S/ASP300S Tissue Processor is an automated system used to process tissue specimens for examination through fixation, dehydration and infiltration.
- Where it went
- Worldwide Distribution - US including U.S. including AZ, CA, CT, DE, FL, GA, HI, IA, ID, IL, IN, KY, LA, MA, MD, MN, MO, MT, NC, NJ, NM, NY, OH, OR, PA, TX, VA, WA, WI, WV and District of Columbia. Internationall to AE, AT, AU , BD , BE, BF, BG,BR, CA, CL, CN, CO, CR, DE, DK, EC, EG, ES, ET, FI, FR, GB, HU, ID, IN, IT, JM, JP, KR, LK, MA, MT, MY, NL, NZ, PA, PE, PH, PL, PT, RO, RU, SA, SE, SG, TH, TR, TW, VN and ZA.
- How much
- 901
Showing the 30 most recent of 40. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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