RegWardenFDA facility compliance records
Facility

THE DAAVLIN DISTRIBUTING CO.

3 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2022: 1 recalls; 2025: 1 recalls; 2026: 1 recalls2017201820192020202112022202320241202512026
  • Recalls (3)

Devices registered here (1)

  • Light, Ultraviolet, Dermatological
    Product code FTC (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4630

Recalls & enforcement

  • Class IIOngoing2026-03-05
    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).
  • Class IIOngoing2025-12-10
    Some of the Calibration/Output Certificates had the outputs reversed.
  • Class IIOngoing2022-04-26
    Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “THE DAAVLIN DISTRIBUTING CO. (FEI 1526255) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1526255-the-daavlin-distributing-co/

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