← FDA ENFORCEMENT
Z-2742-2026Class II

Daavlin Distributing Company

Recalling firm
Daavlin Distributing Company
Product type
Device
Status
Ongoing
Report date
2026-07-22
Distribution
US Nationwide distribution.
Firm state
OH
Product quantity
2 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
Reason for recall

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).

Product description

Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

Code / lot info

Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.