Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Cutera brand truSculpt infrared System (optional) Recalled by Cutera, Inc. Due to Cutera received two adverse events associated with the...
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 Cutera, Inc. directly.
Affected Products
Cutera brand truSculpt infrared System (optional), Massager, Vacuum, radio frequency induced heat, Product is manufactured and distributed by Cutera, Inc., Brisbane, CA The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite. The truSculpt infrared (optional) and RF energies are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
Quantity: 451
Why Was This Recalled?
Cutera received two adverse events associated with the edge of the electrode, when it was pressed against neck skin over the thyroid cartilage and due to the absence of adequate underlying conductive tissue, increased skin heating occurred. Both patients developed linear welts and blisters consistent with partial thickness thermal burns to the skin.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Cutera, Inc.
Cutera, 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