Leica Microsystems, Inc. recalls
Every recall we track for Leica Microsystems, Inc. — 21 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them. 2 are rated “stop using now”.
Recalls per year, by danger level
Recalls from Leica Microsystems, Inc. peaked in 2022 (7); 21 since 2017. 10% rated “stop using now”.
All FDA recall records for Leica Microsystems, Inc. since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 2 | 0 | 2 |
| 2018 | 0 | 5 | 0 | 1 | 6 |
| 2019 | 2 | 0 | 1 | 0 | 3 |
| 2020 | 0 | 1 | 0 | 0 | 1 |
| 2021 | 0 | 1 | 1 | 0 | 2 |
| 2022 | 0 | 3 | 4 | 0 | 7 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Leica Microsystems, Inc. product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Leica Microsystems, Inc. recalls
16 shown- Use cautionMedical device
Leica Microsystems, Inc. recalls Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
Leica Microsystems recalls M530 OHX surgical microscopes with serial numbers listed; overheating risk may cause unexpected shutdowns. Affected units should be checked for serial numbers.
LeicaNov 21, 2022 - Lower riskMedical device
Leica Microsystems, Inc. recalls Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
Leica recalls M530 OHX surgical microscopes with specific serial numbers due to potential inaccurate illumination adjustments when used with BrightCare Plus Luxmeter software.
LeicaAug 26, 2022 - Use cautionMedical device
Leica Microsystems, Inc. recalls Leica Microsystems M220 F12 Microscope Systems
Leica recalls M220 F12 Surgical Microscope systems due to potential risk of optics carrier dropping into surgical field. Affected units have specific serial numbers; contact Leica for details.
LeicaNov 3, 2021 - Lower riskMedical device
Leica Microsystems, Inc. recalls BOND Ready-To-Use Primary Antibody CDX2 (EP25), REF PA0375
Leica Microsystems recalls BOND Ready-To-Use Primary Antibody CDX2 (EP25) REF PA0375 due to potential performance issues. Affected units may not function correctly as per instructions.
LeicaJul 30, 2021 - Use cautionMedical device
Leica Microsystems, Inc. recalls Leica ARveo and M530 OH6 microscope systems.
Leica recalls ARveo and M530 OH6 surgical microscopes due to voltage changes causing unintended shutdowns during procedures. Affected units have specific serial numbers listed in the recall notice.
LeicaMay 20, 2020 - Lower riskMedical device
Leica Microsystems, Inc. recalls BOND Polymer Refine Detection Kit, Catalog No. DS9800. This detection system is for in vitro diagnostic use. Bond
Leica recalls BOND Polymer Refine Detection Kit (DS9800) due to potential suboptimal staining from prolonged refrigeration. Affected kits may not stain tissue properly in lab use.
LeicaNov 18, 2019 - Stop using nowMedical device
Leica Microsystems, Inc. recalls Leica Cryostats, used to produce frozen sample sections for biological, medical and industrial applications, including
Leica Microsystems recalls cryostats with serial numbers from 7466 down that use flammable freezing sprays, which can ignite and cause serious injuries. Affected users should stop using the device immediately.
LeicaMay 3, 2019 - Stop using nowMedical device
Leica Microsystems, Inc. recalls Leica M220 F12 surgical microscope The Leica M220 F12 surgical microscope is an optical instrument for improving the
Leica Microsystems recalls M220 F12 surgical microscopes due to risk of unintended drops into surgical field. Affected units have specific serial numbers. Contact Leica for details.
LeicaJan 2, 2019 - Use cautionMedical device
Leica Microsystems, Inc. recalls BOND Slide Labeler Zebra Printer Model TLP3842 and Model GX4301, for use with BOND-III and BOND-MAX instruments
Leica recalls BOND Slide Labeler Zebra Printers TLP3842 and GX4301 with faulty power supplies that may overheat and cause fire. Affected units have specific part numbers and date codes.
LeicaSep 17, 2018 - Use cautionMedical device
Leica Microsystems, Inc. recalls Leica M525 F20 Surgical Microscope System
Leica recalls M525 F20 Surgical Microscope System with serial numbers listed. The instrument may tip over when swing arm is fully extended, causing potential injury.
LeicaSep 4, 2018 - Use cautionMedical device
Leica Microsystems, Inc. recalls Leica HistoCore SPECTRA CV Coverslipper, used in preparation of histological and cytological tissue samples for
Leica recalls HistoCore SPECT: Improper electrical shielding due to wrong fiberglass hose position may cause shock. Affected units have serial number 102.
LeicaSep 4, 2018 - UnratedMedical device
Leica Microsystems, Inc. recalls Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
Leica recalls M530 OHX Microscope Systems with 100-120V power supply due to a power insert design weakness that could cause electrical issues.
LeicaJun 25, 2018 - Use cautionMedical device
Leica Microsystems, Inc. recalls Leica Biosystems HistoCore SPECTRA ST, Slide Stainer, Automated Product Usage: The intended use of this device is a
Leica recalls HistoCore SPECTRA ST slide stainers with serial numbers 70-78, 111-112, 120-175 due to incorrect safety specifications that could cause electrical shock if a fault occurs.
LeicaJun 13, 2018 - Use cautionMedical device
Leica Microsystems, Inc. recalls Leica Microsystems products labeled as the following: Leica M320 Microscope Systems with Article Numbers 10448419,
Leica Microsystems recalls M320 Microscope Systems with specific article numbers due to risk of screw failure that may cause optics carrier to drop. Affected units include specific serial numbers and article numbers listed in the notice.
LeicaJun 4, 2018 - Lower riskMedical device
Leica Microsystems, Inc. recalls PROVEO 8 Ophthalmic Microscope System optical instrument for improving the visibility of objects through magnification
Leica recalls PROVEO 8 Ophthalmic Microscope Systems with specific serial numbers due to potential focus movement interruptions and display failures during medical use. Affected units may require professional evaluation.
LeicaSep 25, 2017 - Lower riskMedical device
Leica Microsystems, Inc. recalls Nussloch GmbH ASP6025 Tissue Processor
Leica Microsystems recalls ASP6025 Tissue Processors with specific serial numbers due to incorrect voltage labeling on alarm connectors, which could lead to improper operation.
LeicaJun 19, 2017
Leica Microsystems, Inc. recall questions
How many recalls has Leica Microsystems, Inc. had?
21 recalls from Leica Microsystems, Inc. are on record with U.S. safety agencies, from 2017–2022.
What is the most recent Leica Microsystems, Inc. recall?
Leica Microsystems, Inc. recalls Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system, dated Nov 21, 2022. Every Leica Microsystems, Inc. recall is listed on this page, newest first.
What should I do if I have a recalled Leica Microsystems, Inc. product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Leica Microsystems, Inc. recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.