Leica Microsystems, Inc. recall records

7 reported ongoing

8 records in this archive. Latest source date Nov 21, 2022.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system

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...

Class IIReported ongoing

Distribution: US Nationwide

Official source for Leica MICROSYSTEMS Proveo 8, Part Number 10449058, surgical microscope system
FDA device enforcement

Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical microscope system

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...

Class IIReported ongoing

Distribution: US Nationwide

Official source for Leica MICROSYSTEMS Provido, Part Numbers 10448950 (Premium), 10448976 (Standard). Surgical micros...
FDA device enforcement

Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system

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...

Class IIReported ongoing

Distribution: US Nationwide

Official source for Leica MICROSYSTEMS M530 OHX, Part Number 10448737, surgical microscope system
FDA device enforcement

Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

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 "Br...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063
FDA device enforcement

Leica Surgical Operating Microscopes, Arveo, Part Number 10448999

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 "Br...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Leica Surgical Operating Microscopes, Arveo, Part Number 10448999
FDA device enforcement

Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

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 "Br...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737
FDA device enforcement

Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950

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 "Br...

Class IIReported ongoing

Distribution: US Nationwide distribution.

Official source for Leica Surgical Operating Microscopes, PROvido Part Numbers: a. 10448976, b. 10448950
FDA device enforcement

Leica Microsystems M220 F12 Microscope Systems

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 t...

Class IIReported terminated

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 Albani...

Official source for Leica Microsystems M220 F12 Microscope Systems

Reasons in these listed records

  • 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 shu...
  • 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 ...
  • 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...

These examples come from this result page and are not a ranking of every recall reason.

Checking Leica Microsystems, Inc.

Is there a recall on leica microsystems, inc. right now?

This archive contains 8 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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