Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy Recalled by China Daheng Group Inc. Due to Failure to provide calibration procedures to purchasers, as...
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 China Daheng Group Inc. directly.
Affected Products
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Quantity: 238
Why Was This Recalled?
Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers
Where Was This Sold?
This product was distributed to 10 states: CA, FL, IL, KS, KY, NJ, NY, PA, WI, WY
About China Daheng Group Inc.
China Daheng Group 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