Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy… — Class II medical device recall Z-1145-2014
Terminated recall by China Daheng Group Inc., reported 2014-03-26, distributed in CA, FL, IL, KS, KY, NJ, NY, PA…. Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the
| Recall number | Z-1145-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | China Daheng Group Inc., Beijing, China |
| Recall initiated | 2013-07-15 |
| Classified | 2014-03-14 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-04-17 |
| Distributed | CA, FL, IL, KS, KY, NJ, NY, PA, WI, WY |
| Countries outside the US | DK, FR, ID, IN, TR |
| Quantity | 238 |
Product
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Reason for recall
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1145-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.