FDA Device recall Z-2742-2026
Photera 400, phototherapy device
- FDA Device
- Class II
- ongoing
- Published 2026-07-22
On 2026-07-22 the FDA classified a Class II recall of Photera 400, phototherapy device by Daavlin Distributing, citing calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2742-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-03-05 |
| Published | 2026-07-22 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Daavlin Distributing |
| Distribution | US |
Product
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Reason
Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be "4/5" instead of "7" (counts were at ~1000 instead of ~5000).
Identifiers
| code_info | Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2742-2026%22
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