The Recall Desk

Manufacturer

Leica Microsystems, Inc.

40 recalls in our database name Leica Microsystems, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
40
Critical
0
Severe
2
Most recent
2022-12-21

Of the 40 recalls from Leica Microsystems, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (5%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 40

  • HighFDA (Devices)·Z-0475-2023·2022-12-21

    Surgical microscope power supply may overheat and cause unexpected shutdown

    Leica Microsystems is recalling 43 Proveo 8 surgical microscopes nationwide due to a potential power supply defect that may cause device overheating and unexpected shutdown during use.

    Product
    Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0476-2023·2022-12-21

    Leica Provido surgical microscope models at risk of unexpected power shutdown

    Leica Provido surgical microscope systems may experience unexpected shutdown due to power supply overheating. Affected units should be identified by serial number and serviced immediately.

    Product
    Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0477-2023·2022-12-21

    Surgical Microscope Power Supply May Overheat and Cause Unexpected Shutdown

    Leica surgical microscopes (M530 OHX) may experience power supply overheating due to component overstressing, which can cause unexpected device shutdown. 148 units nationwide are affected.

    Product
    Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1850-2022·2022-10-05

    Leica M530 Surgical Microscopes recalled for illumination adjustment defect

    Leica Microsystems is recalling 115 M530 surgical microscopes due to a photodiode component change that causes inaccurate illumination limit adjustment when using the BrightCare Plus feature with Luxmeter.

    Product
    Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1848-2022·2022-10-05

    Leica Surgical Operating Microscopes ARveo 8 recalled for illumination accuracy issue

    Leica Microsystems is recalling 30 ARveo 8 surgical microscopes (Part Number 10449063) distributed nationwide due to a photodiode component change causing inaccurate illumination adjustment when using the BrightCare Plus Luxmeter feature.

    Product
    Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1849-2022·2022-10-05

    Leica Surgical Operating Microscopes recalled for illumination adjustment defect

    Leica Microsystems recalls 25 Leica Surgical Operating Microscopes (Part Number 10448999) due to a photodiode component change causing inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.

    Product
    Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1851-2022·2022-10-05

    Leica Surgical Microscopes: Photodiode Defect Causes Inaccurate Illumination

    Leica Microsystems is recalling 32 surgical operating microscopes due to a photodiode component defect that produces inaccurate illumination adjustment when BrightCare Plus with Luxmeter is used.

    Product
    Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0412-2022·2021-12-29

    Leica M220 F12 Surgical Microscope Optics Carrier May Drop Into Surgical Field

    Leica Microsystems is recalling 2,800 M220 F12 surgical microscopes because the optics carrier may unintentionally drop into the surgical field, risking patient contact. No injuries have been reported.

    Product
    Leica Microsystems M220 F12 Microscope Systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2481-2021·2021-09-22

    Leica BOND Primary Antibody CDX2 Recalled for Performance Specification Issue

    Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (PA0375, Lot 69909) because the product may not perform as specified in its instructions for use. The recall affects 237 units distributed nationwide.

    Product
    BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2399-2020·2020-06-24

    Leica ARveo and M530 OH6 Microscope Systems Recalled for Voltage Issues

    Leica Microsystems is recalling ARveo and M530 OH6 microscope systems because voltage changes may cause equipment shutdown, potentially interrupting surgical procedures.

    Product
    Leica ARveo and M530 OH6 microscope systems.
    Category
    Medical Device
    Distribution
    24 states
  • ModerateFDA (Devices)·Z-0673-2020·2019-12-18

    Leica BOND Polymer Refine Detection Kit Recalled for Storage Issues

    Leica Microsystems is recalling 558 BOND Polymer Refine Detection Kits because they were stored improperly, which may result in 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 rabbi
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1729-2019·2019-06-12

    Leica Cryostats Recalled for Missing Flammable Spray Warning

    Leica Microsystems is recalling 17,179 cryostats because the labels lack warnings about the fire risk associated with flammable freezing sprays.

    Product
    Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including in-vitro diagnostic (IVD) applications.
    Category
    Medical Device
    Distribution
    51 states
  • ModerateFDA (Devices)·Z-0838-2019·2019-02-27

    Leica PROVEO 8 Ophthalmic Microscope System Recalled for Software Defects

    Leica Microsystems is recalling 142 PROVEO 8 Ophthalmic Microscope Systems worldwide due to software anomalies that may cause unexpected movement interruptions or delayed function stops.

    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.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0772-2019·2019-01-30

    Leica M220 F12 Surgical Microscope Recalled for Falling Optics Hazard

    Leica Microsystems is recalling 15 Leica M220 F12 surgical microscopes because the optics may 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 treatmen
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0281-2019·2018-11-07

    Leica BOND Slide Labeler Printers Recalled for Fire Hazard

    Leica Microsystems is recalling BOND Slide Labeler Zebra Printers because the power supply unit may overheat or cause a fire due to 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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0064-2019·2018-10-10

    Leica HistoCore SPECTRA ST Slide Stainer Recalled for Electrical Safety Hazard

    Leica Microsystems is recalling 67 automated slide stainers because a single fault could expose users to hazardous mains voltage.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0019-2019·2018-10-10

    Leica HistoCore SPECTRA CV Coverslipper Recalled for Electrical Shock Risk

    Leica Microsystems is recalling one HistoCore SPECTRA CV Coverslipper unit in Missouri due to a misplaced hose that creates an electrical shock hazard.

    Product
    Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for microscopic analysis for medical diagnostics.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-2555-2018·2018-08-01

    Leica M320 Microscope Systems Recalled for Gas Spring Bracket Failure

    Leica Microsystems is recalling 8,564 M320 Microscope Systems because screws holding the gas spring bracket may fail, causing the optics carrier to drop.

    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
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2016·2016-06-08

    Leica Novocastr Antibody Recalled for Stability Issues

    Leica Microsystems is recalling 270 units of Novocastr Liquid Mouse Monoclonal Antibody RCC because testing showed the product is not stable up to its labeled expiry date.

    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.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1877-2016·2016-06-08

    Leica Microsystems Recalls Unstable CDX2 Antibody Lots

    Leica Microsystems is recalling specific lots of Novocastr CDX2 antibody because testing showed they are not stable until their expiration dates.

    Product
    Novocastr Liquid Mouse Monoclonal Antibody CDX2 (CDX2) is recommended for the assessment of CDX2 protein in normal and neoplastic tissues.
    Category
    Medical Device
    Distribution
    12 states
  • ModerateFDA (Devices)·Z-1704-2016·2016-06-01

    Leica Calretinin Antibody Recalled for Reduced Staining Performance

    Leica Microsystems is recalling Novocastra Calretinin antibodies because they may show reduced staining when used with specific diluent lots.

    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.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Devices)·Z-1499-2016·2016-04-27

    Leica Surgical Microscopes Recalled for Potential Overheating and Smoke

    Leica Microsystems is recalling 381 M525 and M720 surgical microscopes because an electronic component may overheat, causing smoke and smell.

    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.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Leica Microsystems

company

Country
Germany
Founded
1997

Official website

Source: Wikidata (Q880935), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.