Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
VariaBreeze Recalled by New Star Lasers, Inc. Due to FDA inspection found that customers who had received...
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 New Star Lasers, Inc. directly.
Affected Products
VariaBreeze; Catalog number: 7300-0035-2. Podiatry: ablation, vaporization, incision, excision, and coagulation of soft tissue including matrixectomy, periungal and subungal warts, plantar warts, radical nail excision, and neuromas. The temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.)
Quantity: 17 systems
Why Was This Recalled?
FDA inspection found that customers who had received devices with promotional material with outside use indications were not notified when labeling was revised to remove these indications.
Where Was This Sold?
US distribution only.
About New Star Lasers, Inc.
New Star Lasers, Inc. has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report