FDA recall, , Moderate risk
Daavlin Phothera 200 Phototherapy Devices
Phothera 200 Phototherapy Devices have calibration certificates with reversed outputs.
Summary by Recall Canary from the FDA notice
What happened
Daavlin Distributing Company of Bryan, Ohio began a recall of Phothera 200 Phototherapy Devices on December 10, 2025, because some Calibration/Output Certificates had the outputs reversed. The devices are indicated for use to treat diagnosed skin disorders such as Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician.
The FDA added the recall to its Enforcement Report on June 2, 2026, and it was listed in the weekly enforcement report on June 10, 2026. The products were distributed nationwide in the US.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its model number is listed.
Phothera 200 Phototherapy Devices
- Model number
- 210NDT4
- 210NCL4
Recall details
- Company began the recall
- Sold in
US Nationwide distribution.
- Company
- Daavlin Distributing CompanyBryan, Ohio
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98817
- Recall number
- Z-2295-2026
- Quantity recalled
- 368 units
All recalls from Daavlin Distributing Company
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
