Reported Oct 5, 2022 · Ongoing

Leica Surgical Operating Microscopes, M530 OHX, Part Number 10448737

Leica Microsystems, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Leica Microsystems, Inc. · 10 Parkway North blvd ste 300 · deerfield, IL · 60089-6622

Is this the product you have?

    • Leica Surgical Operating Microscopes
    • M530 OHX
    • Part Number 10448737
Lot codes and dates
  • Serial Numbers

    115 of 115 codes

    • 270422001
    • 160322001
    • 230222001
    • 140422001
    • 100122002
    • 60721001
    • 290522001
    • 310522001
    • 81121001
    • 290921001
    • 130122001
    • 111021001
    • 131021001
    • 171021001
    • 10622002
    • 280222002
    • 51121001
    • 90821001
    • 170222001
    • 170522001
    • 11221001
    • 310322001
    • 260522001
    • 270522001
    • 140222001
    • 270422002
    • 30122001
    • 70122001
    • 271121001
    • 300322001
    • 31221001
    • 41221001
    • 230222002
    • 221121001
    • 70422001
    • 60122001
    • 120522001
    • 90921001
    • 200122001
    • 140122001
    • 100122001
    • 100721001
    • 100721002
    • 110721001
    • 20522001
    • 30921001
    • 261021001
    • 210422001
    • 40422001
    • 240122001
    • 140721001
    • 30821001
    • 50821001
    • 280721001
    • 290721001
    • 300721001
    • 300821001
    • 161021001
    • 160921002
    • 110222001
Amount recalled
115 devices

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.