Henry Schein 5702771Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00304040155837), received between Sep 22, 2023 and Jul 30, 2026 — classified as 13 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Power Problem” (10 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Vibration; Power Problem

  This VMSR report summarizes one malfunction event. It was stated on (b)(6)2026, patients have complained that the scaler, ACCLEAN Ultrasonic Scaler, (b)(4), is too strong and painful.

  Patient problems: Laceration(s)

  MAUDE report 50081765 ↗
• InjuryJul 30, 2026Vibration; Power Problem

  This VMSR report summarizes one malfunction event. It was stated on 03/01/2026, patients have complained that the scaler, ACCLEAN Ultrasonic Scaler, (b)(4), is too strong and painful.

  Patient problems: Laceration(s)

  MAUDE report 50081762 ↗
• InjuryJul 30, 2026Overheating of Device

  This VMSR report summarizes one malfunction event. It was stated on (b)(6) 2026, product, ACCLEAN Ultrasonic Scaler, (b)(4), got too hot and caused a minor burn to the doctor's finger.

  Patient problems: Burn(s)

  MAUDE report 50081758 ↗
• InjuryJul 30, 2026Vibration; Power Problem

  This VMSR report summarizes one malfunction event. It was stated on 03/01/2026, patients have complained that the scaler, ACCLEAN Ultrasonic Scaler, (b)(4), is too strong and painful.

  Patient problems: Laceration(s)

  MAUDE report 50081755 ↗
• InjuryJul 30, 2026Vibration; Power Problem

  This VMSR report summarizes one malfunction event. It was stated on (b)(6) 2026, patients have complained that the scaler, ACCLEAN Ultrasonic Scaler, (b)(4), is too strong and painful.

  Patient problems: Laceration(s)

  MAUDE report 50081743 ↗
• InjuryJul 30, 2026Vibration; Power Problem

  This VMSR report summarizes one malfunction event. It was stated on (b)(6) 2026, patients have complained that the scaler, ACCLEAN Ultrasonic Scaler, (b)(4), is too strong and painful.

  Patient problems: Laceration(s)

  MAUDE report 50081739 ↗
• InjuryApr 23, 2026Overheating of Device

  PRODUCT GOT TOO HOT AND CAUSED A MINOR BURN TO THE DOCTOR'S FINGER.

  Patient problems: Burn(s)

  MAUDE report 24974916 ↗
• InjuryApr 23, 2026Vibration; Power Problem

  PATIENTS HAVE COMPLAINED THAT THE SCALER IS TOO STRONG AND PAINFUL.

  Patient problems: Laceration(s)

  MAUDE report 24974903 ↗
• InjuryApr 23, 2026Vibration; Power Problem

  PATIENTS HAVE COMPLAINED THAT THE SCALER IS TOO STRONG AND PAINFUL.

  Patient problems: Laceration(s)

  MAUDE report 24974902 ↗
• InjuryApr 23, 2026Vibration; Power Problem

  PATIENTS HAVE COMPLAINED THAT THE SCALER IS TOO STRONG AND PAINFUL.

  Patient problems: Laceration(s)

  MAUDE report 24974901 ↗
• InjuryApr 23, 2026Vibration; Power Problem

  PATIENTS HAVE COMPLAINED THAT THE SCALER IS TOO STRONG AND PAINFUL.

  Patient problems: Laceration(s)

  MAUDE report 24974900 ↗
• InjuryApr 23, 2026Vibration; Power Problem

  PATIENTS HAVE COMPLAINED THAT THE SCALER IS TOO STRONG AND PAINFUL.

  Patient problems: Laceration(s)

  MAUDE report 24974899 ↗
• MalfunctionApr 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. THE CUSTOMER STATES THE TIP BROKE OFF IN THE 35-YEAR-OLD FEMALE PATIENT'S MOUTH WHILE USING ACCLEAN SCALER (B)(4). IT WAS RETRIEVED WITHOUT INCIDENT NOR FURTHER MEDICAL ATTENTION REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21870361 ↗
• MalfunctionApr 20, 2025Overheating of Device; Overheating of Device

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2024, THEY WERE PERFORMING A SCALING PROCEDURE ON A 56-YEAR-OLD MALE PATIENT, USING ACCLEAN SCALER (B)(4), WHEN THE TIP GOT REALLY HOT AND PATIENT STATED IT WAS BURNING THEM. NO MEDICAL ATTENTION REQUIRED.

  Patient problems: Burn(s)

  MAUDE report 21870360 ↗
• MalfunctionJan 19, 2025Material Integrity Problem; Material Integrity Problem

  THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. THE CUSTOMER STATED THEY WERE PERFORMING PERIO MAINTENANCE ON THE 69-YEAR-OLD MALE PATIENT WITH THIS SCALER PRODUCT (B)(4) WHEN THE BUR, THE ACCLEAN ERGO X-THIN UNIVERSAL, ITEM CODE # 112-6734, BROKE WHILE THEY WERE REMOVING CALCULUS. THEY WERE ABLE TO RETRIEVE THE BROKEN PIECE(S). THERE WAS NO PATIENT INJURY. THE SPEED WAS NOT ABLE TO BE PROVIDED. THEY NORMALLY DISINFECT/ STERILIZE THE ACCLEAN INSTRUMENT BY WIPING WITH CAVICIDE THEN RUNNING IT THROUGH THEIR AUTOCLAVE. THIS IS THE FIRST TIME THIS HAPPENED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21188245 ↗
• MalfunctionOct 13, 2023Insufficient Device Problem Information; Excessive Heating; Insufficient Device Problem Information; Excessive Heating

  A 33 YEAR OLD HYGIENE ASSISTANT WAS CLEANING THE ROOM FOLLOWING A HYGIENE APPOINTMENT. WHEN SHE PICKED UP THE INSERT SHE RECEIVED A BURN ON HER FINGER. THE ASSISTANT DID NOT NEED FURTHER MEDICAL ATTENTION, BUT ITEM HAS POTENTIAL TO BURN PATIENTS OR OTHER STAFF MEMBERS. BOTH ITEMS ARE EXTREMELY HOT AFTER USE. THIS HAPPENED ON (B)(6) 2023 AT 11:30 A.M.

  Patient problems: Burn(s)

  MAUDE report 17928480 ↗
• InjurySep 22, 2023Use of Device Problem; Insufficient Device Problem Information; Excessive Heating; Use of Device Problem; Insufficient Device Problem Information; Excessive Heating

  A 33 YEAR OLD HYGIENE ASSISTANT WAS CLEANING THE ROOM FOLLOWING A HYGIENE APPOINTMENT. WHEN SHE PICKED UP THE INSERT SHE RECEIVED A BURN ON HER FINGER. THE ASSISTANT DID NOT NEED FURTHER MEDICAL ATTENTION, BUT ITEM HAS POTENTIAL TO BURN PATIENTS OR OTHER STAFF MEMBERS. BOTH ITEMS ARE EXTREMELY HOT AFTER USE. THIS HAPPENED ON (B)(6) 2023 AT 11:30 A.M.

  Patient problems: Burn(s)

  MAUDE report 17799662 ↗