Data Foundry

Medical device recalls 2026

Photera 600 3-D — Class II medical device recall Z-2744-2026

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-2744-2026
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)
Quantity212 units
Serial numbers6-09046NB8CL, 6-09047NB8CL, 6-09048NB8CL, 6-09049NB8CL, 6-09050NB8CL, 6-09051NB8CL, 6-09052NB8CL, 6-09053NB8CL, 6-09054NB8CL, 6-09055NB8CL, 6-09057NB8CL, 6-09058NB8CL, 6-09059NB8CL, 6-09060NB8CL, 6-09061NB8CL, 6-09062NB8CL, 6-09063NB8CL, 6-09064NB8CL, 6-09065NB8CL, 6-09066NB8CL, 6-09067NB8CL, 6-09068NB8CL, 6-09110NB8CL, 6-09111NB8CL, 6-09112NB8CL and 180 more

Product

Photera 600 3-D, 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-2744-2026. 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.