Brasseler USA 5026480U0Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00887919821670), received between Apr 25, 2025 and Oct 19, 2025 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionOct 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, THE BACK CAP AND TURBINE OF THE HANDPIECE, BRIO 440F (B)(4) WITH BUR BROKE APART IN THE PATIENT'S MOUTH.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 23333980 ↗
• InjuryApr 25, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THE BACK CAP AND TURBINE WITH BUR BROKE APART IN THE PATIENT'S MOUTH.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911454 ↗