China Daheng Recalls Denlase and Penlase Dental Laser Systems for Missing Calibration Procedures
China Daheng Group Inc. is recalling 238 Denlase and Penlase dental laser systems because the user manuals lacked required calibration procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a documentation and labeling deficiency (missing calibration procedures) rather than a direct physical defect or reported injury, fitting the criteria for a moderate severity recall.
Plain-English summary
China Daheng Group Inc. is recalling 238 units of the Denlase Diode Laser Therapy System and Penlase Dental Laser Therapy System. The recall was initiated because the products failed to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). Specifically, the user manuals did not contain the necessary calibration instructions for these laser devices.
The affected units were distributed in the United States to California, Kansas, Illinois, Pennsylvania, New Jersey, Wisconsin, Wyoming, Kentucky, Florida, and New York. The products were also distributed internationally to India, Indonesia, Turkey, Denmark, and France.
Consumers and healthcare providers should stop using the affected laser systems and contact China Daheng Group Inc. for further instructions on the recall.
The recalled product
- Product
- Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
- Manufacturer
- China Daheng Group Inc.
- Category
- Medical Device — Dental Laser
- Affected units
- 238
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Denlase and Penlase Dental Laser Systems.
Distribution
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