Data Foundry

Medical device recalls 2026

Photera 600 — Class II medical device recall Z-2743-2026

Ongoing recall by Daavlin Distributing Company, reported 2026-07-22, distributed nationwide. Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to

Recall numberZ-2743-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmDaavlin Distributing Company, Bryan, OH, United States
Recall initiated2026-03-05
Classified2026-07-15
Reported by FDA2026-07-22
DistributedNationwide (US)
Quantity26 units
Serial numbers6-07827NB4CL, 6-09022NB4CL, 6-09023NB4CL, 6-09024NB4CL, 6-09025NB4CL, 6-09026NB4CL, 6-09027NB4CL, 6-09028NB4CL, 6-09029NB4CL, 6-09030NB4CL, 6-09031NB4CL, 6-09033NB4CL, 6-09034NB4CL, 6-09035NB4CL, 6-09036NB4CL, 6-09037NB4CL, 6-09038NB4CL, 6-09039NB4CL, 6-09040NB4CL, 6-09041NB4CL, 6-09042NB4CL, 6-09043NB4CL, 6-09044NB4CL, 6-09045NB4CL, 6-09538NB4CL and 1 more

Product

Photera 600, phototherapy device; Ultraviolet Lamp For Dermatologic Disorders

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).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2743-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.