Class II
Medical Device Recall: Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physici
Daavlin Distributing Company · December 10, 2025
Reason for Recall
Some of the Calibration/Output Certificates had the outputs reversed.
Product Description
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physician, Model Numbers 210NDT4 and 210NCL4
Distribution
US Nationwide distribution.
States Affected
NATIONWIDE
Quantity Affected
368 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2295-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.