HENRY SCHEIN 5701072Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00304040090046), received between May 25, 2023 and Jul 30, 2026 — classified as 6 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Detachment of Device or Device Component

  This VMSR report summarizes one malfunction event. It was stated on 03/30/2026, diamond burs were shooting out of the handpiece, Maxima Pro 2, (b)(4), no patient harm/ injury.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50081746 ↗
• InjuryMay 5, 2026Detachment of Device or Device Component

  DIAMOND BURS WERE SHOOTING OUT OF THE HANDPIECE; NO PATIENT HARM/INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25084480 ↗
• InjuryApr 12, 2026Detachment of Device or Device Component

  AFTER REPLACING THE TURBINE, THE HANDPIECE FELL APART IN THE PATIENT'S MOUTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852944 ↗
• MalfunctionJan 19, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. THE CUSTOMER ADVISED THAT THE HEAD CAP OF MODEL (B)(4) CAME UNSCREWED AND POPPED OUT INTO PATIENTS MOUTH. NO INJURY TO PATIENT OR SWALLOWED PARTS, ALL PARTS WERE RETRIEVED FROM THE PATIENTS MOUTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188251 ↗
• MalfunctionJan 19, 2025Device Damaged by Another Device; Device Damaged by Another Device

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. THE HANDPIECE (B)(4) EXPLODED WHILE IT WAS BEING USED ON THE PATIENT. THE PATIENT WAS UNINJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188250 ↗
• InjuryOct 3, 2024Device Damaged by Another Device; Device Damaged by Another Device

  THE HANDPIECE EXPLODED WHILE IT WAS BEING USED ON THE PATIENT. THE PATIENT WAS UNINJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20362040 ↗
• InjurySep 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER ADVISED THAT THE HEAD CAP CAME UNSCREWED AND POPPED OUT INTO PATIENTS MOUTH. NO INJURY TO PATIENT OR SWALLOWED PARTS, ALL PARTS WERE RETRIEVED FROM THE PATIENTS MOUTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20287346 ↗
• MalfunctionJan 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  HANDPIECE HEAD EXPLODED WHILE BEING USED IN A PATIENT'S MOUTH AND BROKE APART. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18532483 ↗
• MalfunctionJan 5, 2024Improper or Incorrect Procedure or Method; Detachment of Device or Device Component; Improper or Incorrect Procedure or Method; Detachment of Device or Device Component

  HANDPEICE HEAD EXPLODED WHILE BEING USED IN A PATIENT'S MOUTH AND BROKE APART. NO HARM TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18449927 ↗
• MalfunctionJun 28, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  HANDPIECE CAP CAME OFF WHILE IN PATIENT'S MOUTH DURING A CROWN PREP PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17218655 ↗
• InjuryMay 25, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  HANDPIECE CAP CAME OFF WHILE IN PATIENT'S MOUTH DURING A CROWN PREP PROCEDURE.

  Patient problems: Choking

  MAUDE report 17008293 ↗