Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MC-500 Multicolor Laser Photocoagulator Recalled by Nidek Inc Due to Laser aperture label was not affixed to 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 Nidek Inc directly.
Affected Products
MC-500 Multicolor Laser Photocoagulator; Distributed by NIDEK Inc. Manufactured by NIDEK CO., Ltd, Japan. For use in ophthalmic and retinal procedures.
Quantity: 29 units (26 already re-labeled)
Why Was This Recalled?
Laser aperture label was not affixed to device prior to shipment in the US.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nidek Inc
Nidek Inc has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report