Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Leica Surgical Operating Microscopes Recalled by Leica Microsystems, Inc. Due to During internal testing, Leica Microsystems has become aware...

Date: August 26, 2022
Company: Leica Microsystems, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Leica Microsystems, Inc. directly.

Affected Products

Leica Surgical Operating Microscopes, ARveo 8, Part Number 10449063

Quantity: 30 devices

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Leica Microsystems, Inc.

Leica Microsystems, Inc. has 40 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report