RecallRadar

FDA Device recall Z-2742-2026

Photera 400, phototherapy device

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

AgencyFDA Device
Recall numberZ-2742-2026
ClassificationClass II
Statusongoing
Initiated2026-03-05
Published2026-07-22
Last updated2026-09-13 11:58 UTC
CompanyDaavlin Distributing
DistributionUS

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_infoSerial 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

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.