Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Class IV New Era medical laser device Recalled by Inova Lasers LLC Due to The firm failed to comply with the applicable...
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 Inova Lasers LLC directly.
Affected Products
Class IV New Era medical laser device
Quantity: 8 units
Why Was This Recalled?
The firm failed to comply with the applicable standards regarding Electronic Product Radiation Control (EPRC) regulations associated with the laser product performance standard and certification.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Inova Lasers LLC
Inova Lasers LLC 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