NIRA Pro+ 174-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850020752454), received between Dec 30, 2025 and Dec 30, 2025 — classified as 1 injury.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryDec 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6) 2025, A CONSUMER REPORTED SUSTAINING A FACIAL BURN AFTER USING THE NIRA PRO+ LASER. THE DEVICE WAS APPLIED TO THE LOWER CHEEK ON DRY, CLEAN SKIN. SHORTLY AFTER USE, THE CONSUMER NOTICED REDNESS AND A BURNING SENSATION, WHICH PROGRESSED TO BLISTER FORMATION WITHIN HOURS. THE CONSUMER DISCONTINUED FURTHER USE IMMEDIATELY AND SELF-TREATED WITH TOPICAL NEOSPORIN. FOLLOW-UP COMMUNICATION CONFIRMED A LOCALIZED BURN WITH BLISTER FORMATION ON THE LOWER CHEEK. SHE WAS ADVISED TO DISCONTINUE USE AND TO CONSULT A HEALTHCARE PROVIDER OR DERMATOLOGIST. THE DEVICE WAS RETURNED ON 04 SEP 2025 FOR EVALUATION UNDER THE COMPANY'S REFUND AND INVESTIGATION PROCESS, AND NIRA RECEIVED IT ON (B)(6) 2025. DURING FOLLOW-UP, THE CONSUMER REPORTED THAT THE AREA WAS HEALING BUT REMAINED DISCOLORED. ON (B)(6) 2025, DURING A FOLLOW-UP CALL, SHE REPORTED RESIDUAL SCARRING ON THE AFFECTED SITE AND PROVIDED A NOTE FROM HER DERMATOLOGIST RECOMMENDING RESURFACING TREATMENT. BECAUSE THE BURN RESULTED IN PERSISTENT SCARRING AND REQUIRED MEDICAL CONSULTATION, THE MANUFACTURER CLASSIFIED THIS EVENT AS A SERIOUS INJURY.

  Patient problems: Blister; Scar Tissue

  MAUDE report 23922870 ↗