Class II — Daavlin Distributing Company
| Recalling firm | THE DAAVLIN DISTRIBUTING CO. |
|---|---|
| Registered facility | THE DAAVLIN DISTRIBUTING CO. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Some of the Calibration/Output Certificates had the outputs reversed. |
| 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 |
| Quantity | 368 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2025-12-10 |
| Classified | 2026-06-02 |
| Recall number | Z-2295-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Daavlin Distributing Company (Z-2295-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98817/
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