FDA recall Z-2295-2026

Daavlin Distributing Company · Class II · device

Product

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

Reason for recall

Some of the Calibration/Output Certificates had the outputs reversed.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2025-12-10
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bryan, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2295-2026