Recall Z-2295-2026 ยท FTC Light, Ultraviolet, Dermatological
Daavlin Distributing Company
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
| Date | Jun 2, 2026 (initiated Dec 10, 2025) |
| Status | Open, Classified |
| Reason | Some of the Calibration/Output Certificates had the outputs reversed. |
| Root cause | Labeling Change Control |
| Action | An URGENT: MEDICAL DEVICE ADVISORY NOTICE dated 12/11/25 was sent to customers. Dual calibration allows you to treat at the surface (0 ) of the device or at 9 inches (9 ) away. It has come to our attention that some of the Calibration/Output Certificates had the outputs reversed. Actions to be taken by the Customer/User: Talk to your physician regarding treatment plans with the new information listed below. If you have any questions or concerns, please do not hesitate to contact our office at (800) 322-8546. Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. Thank you for your coopera |
| Quantity | 368 units |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K220840 | 1 Series Phototherapy Equipment Daavlin Distributing Co., Apr 22, 2022 |