Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
NIDEK Specular Microscope Recalled by Nidek, Inc. Due to The electromagnetic noise exceeded the upper limit of...
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 Nidek, Inc. directly.
Affected Products
NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
Quantity: 13 devices
Why Was This Recalled?
The electromagnetic noise exceeded the upper limit of the Electromagnetic Compatibility Standard (EMC: IEC 60601-1-2)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nidek, Inc.
Nidek, Inc. has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report