Phothera 200 — Class II medical device recall Z-2295-2026
Ongoing recall by Daavlin Distributing Company, reported 2026-06-10, distributed nationwide. Some of the Calibration/Output Certificates had the outputs reversed.
| Recall number | Z-2295-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Daavlin Distributing Company, Bryan, OH, United States |
| Recall initiated | 2025-12-10 |
| Classified | 2026-06-02 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 368 units |
| Serial numbers | 2-03292NB4DT, 2-03308NB4DT, 2-03309NB4DT, 2-03310NB4DT, 2-03311NB4DT, 2-03312NB4DT, 2-03313NB4DT, 2-03314NB4DT, 2-03315NB4DT, 2-03316NB4DT, 2-03317NB4DT, 2-03318NB4DT, 2-03319NB4DT, 2-03320NB4DT, 2-03321NB4DT, 2-03322NB4DT, 2-03323NB4DT, 2-03326NB4DT, 2-03328NB4DT, 2-03329NB4DT, 2-03330NB4DT, 2-03331NB4DT, 2-03332NB4DT, 2-03333NB4DT, 2-03334NB4DT and 343 more |
| Model numbers | 210NCL4, 210NDT4 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2295-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.