CLASS II Device recall · Reported 26 Mar 2014 · FDA Enforcement Report
Denlase: Diode Laser Therapy System and Penlase recalled
China Daheng Group is recalling Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical, distributed in 10 states. The recall was initiated on 15 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1145-2014
- FDA event ID
- 67520
- Recalling firm
- China Daheng Group, Beijing
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Jul 2013
- FDA classified
- 14 Mar 2014
- Reported
- 26 Mar 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Visit
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 15 Jul 2013 | Recall initiated by company | |
| 14 Mar 2014 | Classified by FDA | +242 days |
| 26 Mar 2014 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments.
Where it was distributed
CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
CaliforniaFloridaIllinoisKansasKentuckyNew JerseyNew YorkPennsylvaniaWisconsinWyoming
Questions about this recall
Is Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical recalled?
Yes. China Daheng Group recalled Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical on 15 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1145-2014.
Why was it 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
Which lots are affected?
Denlase and Penlase Dental Laser Systems.
Where was it sold?
CA, KS, IL, PA, NJ, WI, WY, KY, FL and NY India, Indonesia, Turkey, Denmark, and France,
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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