FDA Medical devices recall ·
Photera 400, phototherapy device recall
- Recall number
- Z-2742-2026
- Date
- (initiated March 5, 2026)
- Company / brand
- Daavlin Distributing Company
205 W Bement St, Bryan, OH, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Why was it recalled?
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.
Distribution
US Nationwide distribution.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2742-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.