Henry Schein 5701450Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00304040110881), received between Sep 27, 2024 and Sep 18, 2026 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Material Integrity Problem” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2026Mechanical Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50831202 ↗
• MalfunctionJan 19, 2025Material Integrity Problem; Material Integrity Problem

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. HANDPIECE (B)(4) EXPLODED WHILE IT WAS BEING USED ON A PATIENT. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188253 ↗
• InjurySep 27, 2024Material Integrity Problem; Material Integrity Problem

  HANDPIECE EXPLODED WHILE IT WAS BEING USED ON A PATIENT. NO PATIENT INJURY.

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

  MAUDE report 20322335 ↗