Henry Schein Maxima 5702660Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00304040153857), received between Jul 27, 2023 and Jan 30, 2025 — classified as 14 injuries, 1 malfunction.

The most frequently reported specific device problem is “Use of Device Problem” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• InjuryJan 30, 2025Temperature Problem; Temperature Problem

  TWO FEMALE PATIENTS WERE BURNED FROM THE MAXIMA ELITE 2 CONTRA ANGLE ON TWO DIFFERENT OCCASIONS. ONE TIME WAS ON (B)(6) 2024 WHILE THE OTHER WAS ON (B)(6) 2024. ONE PATIENT IS 43 YEARS OLD WHILE THE OTHER IS 67 YEARS OLD. IT IS NOT CLEAR WHICH HAD THE BURN WHERE BUT ONE WAS ON THE LIP WHILE THE OTHER WAS ON THE BUCCAL MUSCOSA. THE TYPE OF BURN WAS A LARGE ULCER. VITAMIN E WAS PLACED ON THE AREA FOR THE BURN AND NO FURTHER TREATMENT NEEDED. IT WAS THE HEAD PART THAT GOT HOT. ONE PATIENT IS DOING FINE AS OF TODAY WHILE THE OTHER THEY HAVE NOT SEEN SINCE. ADDITIONAL CORRESPONDENCE FROM THE DOCTOR WAS RECEIVED ON (B)(6) 2024: IT WAS STATED THAT BOTH A PATIENT AND STAFF MEMBER RECEIVED A BURN FROM THE HANDPIECE IS THIS CORRECT? NO, 2 PATIENTS WERE BURNED. WE WERE ALSO MADE AWARE THAT IT WAS A MALE AND FEMALE. WHICH WAS THE PATIENT AND WHICH WAS THE STAFF MEMBER? NO, 2 FEMALE PATIENTS. COULD YOU SHARE THE AGE OF BOTH THE PATIENT AND STAFF MEMBER? 43 YEARS OLD AND 67 YEARS OLD. WHERE WAS THE BURN RECEIVED ON EACH? ONE ON THE LIP AND THE OTHER ON THE BUCCAL MUCOSA. WHAT TYPE OF BURN WAS RECEIVED? IT WAS A LARGE ULCER. WHAT WAS DONE TO TREAT THE BURN RECEIVED? VITAMIN E WAS PLACED. WHAT PAR

  Patient problems: Burn(s); Superficial (First Degree) Burn

  MAUDE report 21270988 ↗
• InjuryJan 30, 2025Temperature Problem; Temperature Problem

  TWO FEMALE PATIENTS WERE BURNED FROM THE MAXIMA ELITE 2 CONTRA ANGLE ON TWO DIFFERENT OCCASIONS. ONE TIME WAS ON (B)(6)2024 WHILE THE OTHER WAS (B)(6)2024. ONE PATIENT IS 43 YEARS OLD WHILE THE OTHER IS 67 YEARS OLD. IT IS NOT CLEAR WHICH HAD THE BURN WHERE BUT ONE WAS ON THE LIP WHILE THE OTHER WAS ON THE BUCCAL MUSCOSA. THE TYPE OF BURN WAS A LARGE ULCER. VITAMIN E WAS PLACED ON THE AREA FOR THE BURN AND NO FURTHER TREATMENT NEEDED. IT WAS THE HEAD PART THAT GOT HOT. ONE PATIENT IS DOING FINE AS OF TODAY WHILE THE OTHER THEY HAVE NOT SEEN SINCE. ADDITIONAL CORRESPONDENCE FROM THE DOCTOR WAS RECEIVED ON 12/18/2024: IT WAS STATED THAT BOTH A PATIENT AND STAFF MEMBER RECEIVED A BURN FROM THE HANDPIECE IS THIS CORRECT? NO, 2 PATIENTS WERE BURNED. WE WERE ALSO MADE AWARE THAT IT WAS A MALE AND FEMALE. WHICH WAS THE PATIENT AND WHICH WAS THE STAFF MEMBER? NO, 2 FEMALE PATIENTS. COULD YOU SHARE THE AGE OF BOTH THE PATIENT AND STAFF MEMBER? 43 YEARS OLD AND 67 YEARS OLD. WHERE WAS THE BURN RECEIVED ON EACH? ONE ON THE LIP AND THE OTHER ON THE BUCCAL MUCOSA. WHAT TYPE OF BURN WAS RECEIVED? IT WAS A LARGE ULCER. WHAT WAS DONE TO TREAT THE BURN RECEIVED? VITAMIN E WAS PLACED. WHAT PART OF T

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21270923 ↗
• InjuryJan 8, 2025Excessive Heating; Excessive Heating

  TWO FEMALE PATIENTS WERE BURNED FROM THE MAXIMA ELITE 2 CONTRA ANGLE ON TWO DIFFERENT OCCASIONS. ONE TIME WAS ON (B)(6) 2024 WHILE THE OTHER WAS (B)(6) 2024. ONE PATIENT IS 43 YEARS OLD WHILE THE OTHER IS 67 YEARS OLD. IT IS NOT CLEAR WHICH HAD THE BURN WHERE BUT ONE WAS ON THE LIP WHILE THE OTHER WAS ON THE BUCCAL MUSCOSA. THE TYPE OF BURN WAS A LARGE ULCER. VITAMIN E WAS PLACED ON THE AREA FOR THE BURN AND NO FURTHER TREATMENT NEEDED. IT WAS THE HEAD PART THAT GOT HOT. ONE PATIENT IS DOING FINE AS OF TODAY WHILE THE OTHER THEY HAVE NOT SEEN SINCE. ADDITIONAL CORRESPONDENCE FROM THE DOCTOR WAS RECEIVED ON 12/18/24: IT WAS STATED THAT BOTH A PATIENT AND STAFF MEMBER RECEIVED A BURN FROM THE HANDPIECE IS THIS CORRECT? NO, 2 PATIENTS WERE BURNED . WE WERE ALSO MADE AWARE THAT IT WAS A MALE AND FEMALE. WHICH WAS THE PATIENT AND WHICH WAS THE STAFF MEMBER? NO, 2 FEMALE PATIENTS. COULD YOU SHARE THE AGE OF BOTH THE PATIENT AND STAFF MEMBER? 43 YEARS OLD AND 67 YEARS OLD. WHERE WAS THE BURN RECEIVED ON EACH? ONE ON THE LIP AND THE OTHER ON THE BUCCAL MUCOSA. WHAT TYPE OF BURN WAS RECEIVED? IT WAS A LARGE ULCER. WHAT WAS DONE TO TREAT THE BURN RECEIVED? VITAMIN E WAS PLACED. WHAT PART OF

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 21108022 ↗
• MalfunctionDec 4, 2024Temperature Problem; Temperature Problem

  DEVICE WAS OVER HEATING DURING TREATMENT OF PATIENT. NO INJURIES OR BURNS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20843640 ↗
• InjuryNov 13, 2024Excessive Heating; Excessive Heating

  DEVICE WAS OVER HEATING DURING TREATMENT OF PATIENT. NO INJURIES OR BURNS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20676070 ↗
• InjuryOct 17, 2024Mechanical Problem; Mechanical Problem

  DOCTOR WAS USING THE HANDPIECE ON THE PATIENT WHEN THE BUR DISLODGED FROM THE CHUCK AND WAS SWALLOWED BY THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20470114 ↗
• InjurySep 20, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  DOCTOR WAS USING THE HANDPIECE ON THE PATIENT WHEN THE BUR DISLODGED FROM THE CHUCK AND WAS SWALLOWED BY THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20267963 ↗
• InjuryJul 17, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER DESCRIBED THE HANDPIECES ARE STILL HAVING OVERHEATING ISSUES.

  Patient problems: Burn(s)

  MAUDE report 19759695 ↗
• InjuryJun 19, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE CUSTOMER DESCRIBED THE HANDPIECES ARE STILL HAVING OVERHEATING ISSUES.

  Patient problems: Burn(s)

  MAUDE report 19570635 ↗
• InjuryAug 23, 2023Use of Device Problem; Use of Device Problem

  AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 17600814 ↗
• InjuryAug 23, 2023Use of Device Problem; Use of Device Problem

  AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 17600813 ↗
• InjuryAug 23, 2023Use of Device Problem; Use of Device Problem

  AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 17600811 ↗
• InjuryJul 27, 2023Use of Device Problem; Excessive Heating; Use of Device Problem; Excessive Heating

  AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 17405968 ↗
• InjuryJul 27, 2023Use of Device Problem; Excessive Heating; Use of Device Problem; Excessive Heating

  AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 17405948 ↗
• InjuryJul 27, 2023Use of Device Problem; Excessive Heating; Use of Device Problem; Excessive Heating

  AFTER SEVERAL USES, THE PRODUCT HEATED UP AND BURNED THREE (3) PATIENTS.

  Patient problems: Burn(s)

  MAUDE report 17405862 ↗