UltraClear AS-BK-00055Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00850039149023), received between Feb 19, 2026 and Feb 19, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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 16, 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.

• InjuryFeb 19, 2026Improper or Incorrect Procedure or Method

  PATIENT WAS REPORTED AS HAVING LESIONS ON FACE THAT DEVELOPED AFTER ULTRACLEAR TREATMENT. PHOTOGRAPHS PROVIDED OF THE FIRST 11 DAYS POST TREATMENT SHOWED REDNESS AND CRUSTING THROUGH THE FIRST 5 DAYS DEVELOPING INTO OPEN LESIONS BY DAY 11. THE TREATING PHYSICIAN PRESCRIBED HYPOCHLOROUS ACID SPRAY ON DAY 5 TO REDUCE REDNESS AND INFLAMMATION. ON DAY 9 THE PATIENT WAS PRESCRIBED KEFLEX (CEPHALEXIN, AN ANTIBIOTIC) AS BACTERIAL INFECTION WAS SUSPECTED. MEMBERS OF ACCLARO'S MEDICAL ADVISORY BOARD (MAB) REVIEWED THE PROVIDED PHOTOGRAPHS. THE MAB STATED THAT HAD THESE SYMPTOMS PRESENTED IN CLINIC THEY WOULD HAVE PRESCRIBED 1000MG OF VALTREX 3X PER DAY AND CULTURE THE LESIONS AS SOON AS AN OUTBREAK OCCURRED. MAB STATED THEY WOULD PRESCRIBE KEFLEX OR A SIMILAR ANTIBIOTIC AND IF THE CULTURE RESULTS INDICATED MRSA, THEY WOULD PRESCRIBE DOXYCYCLINE OR TETRACYCLINE. THIS INFORMATION WAS COMMUNICATED WITH THE REPORTING CLINIC. THE CLINIC STATED THEY DID NOT PRESCRIBE VALTREX AS THERE WAS NO HISTORY OF HERPES IN THE PATIENT, SO THEY PRESCRIBED KEFLEX. THE CLINIC CULTURED THE LESIONS AND THE RESULTS INDICATED MRSA. THE PATIENT WAS THEN PRESCRIBED VALTREX AND TETRACYCLINE. IT IS THE OPINION OF ACCLA

  Patient problems: Skin Infection

  MAUDE report 24388419 ↗