Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Recalled by Ellipse A/S Due to Failure to provide the required instructions specifying a...
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 Ellipse A/S directly.
Affected Products
Ellipse ND: YAG Laser applicator for Ellipse Multiflex Medical Laser Products.
Quantity: US - 14
Why Was This Recalled?
Failure to provide the required instructions specifying a procedure and schedule for calibration of the measurement system.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ellipse A/S
Ellipse A/S has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report