Recall
FDAHealthMarch 5, 2026

Daavlin Distributing Company — Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

⚠️ 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).

Is this relevant to me?

Geography
Nationwide
Source agency
FDA
Category
Health
Published
March 5, 2026

US Nationwide distribution.

What's affected?

Product
Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders
Lot code
Serial Numbers: 4-01440NB10CL, 2 4-01441NB10CL.

Additional details

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

What should I do?

Recommended action

Class II recall. Voluntary: Firm initiated Quantity affected: 2 units.

View original FDA notice →

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