Brasseler USA 5026059U0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887919774594), received between Mar 20, 2025 and Jul 14, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 14, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, BACK CAP CAME OFF AND TURBINE DISLODGED FROM THE HANDPIECE, BRIO 440 (B)(4), DURING PROCEDURE, PATIENT SUFFERED FROM LOWER RIGHT CHEEK ABRASION.

  Patient problems: Abrasion

  MAUDE report 22492189 ↗
• InjuryMar 20, 2025Improper or Incorrect Procedure or Method; Material Integrity Problem; Improper or Incorrect Procedure or Method; Material Integrity Problem

  BACK CAP CAME OFF AND TURBINE DISLODGED FROM THE HANDPIECE DURING PROCEDURE; PATIENT SUFFERED LOWER RIGHT CHEEK ABRASION.

  Patient problems: Abrasion

  MAUDE report 21657675 ↗