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Daavlin Distributing Company FDA Recalls
6 recalls on file across devices, 0 of them Class I and 6 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Photera 400, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersClass IIMar 5, 2026Calibrated Output was not calculating correctly - UV Sensor |
| Photera 600 3-D, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersClass IIMar 5, 2026Calibrated Output was not calculating correctly - UV Sensor |
| Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic DisordersClass IIMar 5, 2026Calibrated Output was not calculating correctly - UV Sensor |
| Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, PsorClass IIDec 10, 2025Some of the Calibration/Output Certificates had the outputs |
| 4 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. M4 Class IIApr 26, 2022Software issue, resuming an interrupted treatment will resul |
| 1 Series CX phototherapy units equipped with Daavlin's ClearLink Control System software versions v3.03h and 3.04v. ModeClass IIApr 26, 2022Software issue, resuming an interrupted treatment will resul |