Henry Schein MaximaRecalls & reported problems across all models
Henry Schein, Inc. · 3 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 16
- Recalls
- 0
We found 3 models of Henry Schein Maxima by Henry Schein, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jul 27, 2023 and Oct 19, 2025 — classified as 16 injuries, 4 malfunctions.
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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Henry Schein Maxima problems
Device problems
- Use of Device Problem6
- Excessive Heating5
- Detachment of Device or Device Component3
- Temperature Problem3
- Burst Container or Vessel2
- Insufficient Device Problem Information2
- Material Integrity Problem2
- Mechanical Problem1
Patient problems
- Burn(s)10
- No Clinical Signs, Symptoms or Conditions4
- Superficial (First Degree) Burn3
- Foreign Body In Patient2
- Laceration(s)2
Henry Schein Maxima models
3 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Henry Schein Maxima 5702660Handpiece, air-powered, dental15 reports
- Henry Schein Maxima 5700108Handpiece, air-powered, dental4 reports
- Henry Schein Maxima 1125681Handpiece, air-powered, dental1 report
Recent Henry Schein Maxima adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionOct 19, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
THIS VMSR REPORT SUMMARIZES ONE MALFUNCTION EVENT. IT WAS STATED ON (B)(6) 2025, WHILE DOCTOR WAS WORKING ON CHILD PATIENT, BUR SLIPPED OUT OF CHUCK FROM THE HANDPIECE, MAXIMA ELITE MINI L (B)(4), AND CUT CHILD'S CHEEK.
Patient problems: Laceration(s)
MAUDE report 23333981 ↗InjuryJul 18, 2025Detachment of Device or Device Component; Material Integrity Problem; Detachment of Device or Device Component; Material Integrity Problem
WHILE DOCTOR WAS WORKIN ON CHILD PATIENT, BUR SLIPPED OUT OF CHUCK AND CUT CHILD'S CHEEK.
Patient problems: Laceration(s)
MAUDE report 22541661 ↗MalfunctionApr 22, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MAXIMA ELITE 1:5 - T1 LINE HANDPIECE OVERHEATED. 1 EVENT RESULTED IN THE PATIENT BEING SLIGHTLY BURNED WITH NO INTERVENTION.
Patient problems: Burn(s)
MAUDE report 21880828 ↗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 ↗MalfunctionMay 24, 2024Burst Container or Vessel; Burst Container or Vessel
AT FIRST, THE DOCTOR WAS HAVING "PRESSURE AND NOT CUTTING ISSUES" WITH THE PRODUCT. THE DOCTOR SENT THE PRODUCT OVER TO PRO REPAIR. THEN, AFTER RECEIVING THE PRODUCT, THE DOCTOR USED THE HANDPIECE ON A 6 YEAR OLD MALE PATIENT AND IT EXPLODED IN THE PATIENTS MOUTH. THE PATIENT WAS SEDATED AND THEY WERE ABLE TO RETRIEVE ALL THE PARTS. THE PATIENT IS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19391236 ↗InjuryMay 21, 2024Burst Container or Vessel; Burst Container or Vessel
AT FIRST, THE DOCTOR WAS HAVING "PRESSURE AND NOT CUTTING ISSUES" WITH THE PRODUCT. THE DOCTOR SENT THE PRODUCT OVER TO PRO REPAIR. THEN, AFTER RECEIVING THE PRODUCT, THE DOCTOR USED THE HANDPIECE ON A 6 YEAR OLD MALE PATIENT AND IT EXPLODED IN THE PATIENTS MOUTH. THE PATIENT WAS SEDATED AND THEY WERE ABLE TO RETRIEVE ALL THE PARTS. THE PATIENT IS IN GOOD CONDITION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19359659 ↗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 ↗
Other Henry Schein, Inc. products
All Henry Schein, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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