Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
MelaFind Device Recalled by MELA Sciences, Inc. Due to The probability and histogram data within the Melafind's...
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 MELA Sciences, Inc. directly.
Affected Products
MelaFind Device, Model MF 100 US, optical diagnostic device for melanoma detection.
Quantity: 65 units
Why Was This Recalled?
The probability and histogram data within the Melafind's device displayed user interface lacks approval (not included in the PMA supplement).
Where Was This Sold?
This product was distributed to 21 states: AL, CA, CO, CT, FL, HI, IL, MD, MA, MI, NH, NJ, NY, OH, PA, RI, SC, TN, TX, VA, WA
About MELA Sciences, Inc.
MELA Sciences, 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