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Hall PRO7000DERecalls & reported problems

Conmed Corporation · Hall OralMax Elite High Speed Drill · Class 1

Quick summary

This Conmed Hall OralMax Elite high-speed drill is a powered surgical drill. Reports mostly describe the handpiece running hot, becoming noisy, and overheating during testing, with 2 mentioning burns. There are 24 reports that name its identifier, with no deaths and 2 injuries, and no recalls name this device. Reports fell from 13 in the prior 12 months to 1 in the last 12 months.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
24
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 10845854040904), received between Apr 22, 2024 and Dec 16, 2025 — classified as 2 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Overheating of Device” (24 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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 3 reportsMay 2024: 2 reportsJun 2024: 3 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 2 reportsJan 2025: 1 reportsFeb 2025: 5 reportsMar 2025: 1 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 1 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Overheating of Device24

Patient problems

  • No Clinical Signs, Symptoms or Conditions22
  • Burn(s)2

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 16, 2025Overheating of Device; Overheating of Device

    A DISTRIBUTOR REPORTED ON BEHALF OF A CUSTOMER THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS IN USE DURING PRE-OPERATIVE TESTING ON AN UNKNOWN DATE, AND ¿THIS HANDPIECE IS FOUND TO HAVE WEIRD NOISE AND OVER-HEATED OF THE MOTOR WHILE IT IS BEING USED.¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR ANY PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23815324 ↗
  • MalfunctionOct 1, 2025Overheating of Device; Overheating of Device

    A CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS OBSERVED IN PRE-OPERATIVE TESTING ON APPROXIMATELY (B)(6) 2025, AND ¿BUR LOCK, OVER HEATED, NOT CONNECTING¿ WAS FOUND. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR ANY PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23189302 ↗
  • MalfunctionJun 23, 2025Overheating of Device; Overheating of Device

    A CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS FOUND TO BE ¿RUNNING HOT¿ IN PRE-OPERATIVE TESTING ON AN UNKNOWN DATE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR ANY PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22306483 ↗
  • MalfunctionJun 12, 2025Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE THAT PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS FOUND DURING A NON-SURGICAL PROCEDURE ON APPROXIMATELY (B)(6) 2025 WHEN IT WAS REPORTED ¿GETS TOO HOT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22193864 ↗
  • MalfunctionApr 16, 2025Overheating of Device; Overheating of Device

    DURING A REQUEST FOR SERVICE MADE ON (B)(6) 2025, A CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS ¿GETTING HOT¿. FURTHER ASSESSMENT FOUND THIS EVENT OCCURRED DURING AN UNNAMED PATIENT PROCEDURE ON AN UNKNOWN DATE. THERE WAS NO INJURY TO ANY PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21851469 ↗
  • MalfunctionMar 7, 2025Overheating of Device; Overheating of Device

    A CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL WAS USED IN AN UNNAMED PROCEDURE ON AN UNKNOWN DATE AND BECAME ¿NOISY AND HOT¿. THE PROCEDURE WAS COMPLETED WITH A ¿NEW HANDPIECE¿, AND WITH NO DELAY ¿EXCEPT TO GET THE ALTERNATE DEVICE¿, WHICH WAS NEARBY. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THE CUSTOMER WAS UNABLE TO PROVIDE FURTHER DETAILS ABOUT THE EVENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21546339 ↗
  • MalfunctionFeb 21, 2025Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL, WAS BEING USED ON APPROXIMATELY (B)(6) 2025 AND "GETS HOT¿. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21434127 ↗
  • MalfunctionFeb 18, 2025Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH-SPEED DRILL, DEVICE WAS BEING USED ON APPROXIMATELY (B)(6) 2025 DURING A NON-SURGICAL EVENT WHEN IT WAS REPORTED ¿LOUD HOT.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21401416 ↗
  • MalfunctionFeb 10, 2025Overheating of Device; Overheating of Device

    A CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS ¿NOISY AND HOT¿ IN A NON-SURGICAL EVENT ON 28JAN25. THERE WAS NO PATIENT INVOLVEMENT AND NO REPORT OF INJURY OR IMPACT TO ANY USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21343156 ↗
  • MalfunctionFeb 6, 2025Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL, DEVICE WAS BEING USED ON A 16JAN25 DURING AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿GETS HOT.". THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21321003 ↗
  • MalfunctionFeb 3, 2025Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE PRO7000DE HALL ORALMAX ELITE HIGH SPEED DRILL, WAS BEING USED ON APPROXIMATELY (B)(6) 2025 AND WAS ¿GETTING HOT¿. THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21292526 ↗
  • MalfunctionJan 23, 2025Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL, WAS BEING USED ON (B)(6) 2025 AND IT "GETS HOT".THERE WAS NO IMPACT OR INJURY FOR THE PATIENT OR USER. THE SURGERY WAS COMPLETED WITH NO DELAY. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21216899 ↗
  • MalfunctionDec 17, 2024Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE, PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿THE DEVICE IS NOT CUTTING TOOTH/BONE AND GETS VERY HOT DURING USE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT OR THE USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20950477 ↗
  • MalfunctionDec 13, 2024Overheating of Device; Overheating of Device

    A CUSTOMER REPORTED THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE WAS ¿GETTING HOT NEED LOANER¿. THE REPORT WAS RECEIVED THROUGH THE SERVICE AND REPAIR DEPARTMENT, WITH NO FURTHER INFORMATION ABOUT THE EVENT. FURTHER ASSESSMENT FOUND THAT THE CUSTOMER WAS UNAWARE OF THE DEVICE BEING INVOLVED IN ANY EVENT INVOLVING A PATIENT, OR CAUSING ANY INJURY, WHETHER TO A PATIENT OR USER. SHE THOUGHT THAT ONE OF THE DOCTORS WAS PROBABLY USING THE DEVICE AND ¿FELT IT GETTING WARM IN HIS HAND¿. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR ANY PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20923956 ↗
  • MalfunctionOct 25, 2024Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE, PRO7000DE, HALL ORALMAX ELITE HIGH-SPEED DRILL, WAS REPORTED ON AN UNKNOWN DATE AS, ¿OVERHEATS.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT AS THIS WAS FOUND DURING A NON-SURGICAL EVENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20531657 ↗
  • MalfunctionSep 11, 2024Overheating of Device; Overheating of Device

    IT WAS REPORTED THAT THE PRO7000DE HALL ORALMAX ELITE HIGH SPEED DRILL, DEVICE WAS BEING USED ON AN UNKNOWN DATE DURING A NON-SURGICAL EVENT WHEN IT WAS REPORTED ¿GETS HOT.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20188810 ↗
  • MalfunctionJun 5, 2024Overheating of Device; Overheating of Device

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL WAS BEING USED ON (B)(6) 2024 AND ¿ONLY ONE OF THESE WERE HOT DURING A SURGERY, BUT SHE DIDN'T KNOW WHICH AND THE CUSTOMER WASN'T COMFORTABLE KEEPING THEM WITHOUT BEING EVALUATED¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19467968 ↗
  • MalfunctionJun 5, 2024Overheating of Device; Overheating of Device

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL WAS BEING USED ON (B)(6) 2024 AND ¿ONLY ONE OF THESE WERE HOT DURING A SURGERY, BUT SHE DIDN'T KNOW WHICH AND THE CUSTOMER WASN'T COMFORTABLE KEEPING THEM WITHOUT BEING EVALUATED¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19467967 ↗
  • MalfunctionJun 5, 2024Overheating of Device; Overheating of Device

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL WAS BEING USED ON (B)(6) 2024 AND ¿ONLY ONE OF THESE WERE HOT DURING A SURGERY, BUT SHE DIDN'T KNOW WHICH AND THE CUSTOMER WASN'T COMFORTABLE KEEPING THEM WITHOUT BEING EVALUATED¿. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19467966 ↗
  • MalfunctionMay 28, 2024Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE, PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE WHEN IT WAS REPORTED, ¿UNIT OVERHEATING EVEN THOUGH WE HAVE CHANGED OUT THE BUR GUARDS MULTIPLE TIMES.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19403696 ↗
  • MalfunctionMay 20, 2024Overheating of Device; Overheating of Device

    THE CUSTOMER REPORTED THAT THE DEVICE, PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL, WAS ¿EXCESSIVE HEAT FAILURE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19350154 ↗
  • MalfunctionApr 23, 2024Overheating of Device; Overheating of Device

    A CUSTOMER REPORTED THAT DURING PRE-OPERATIVE TESING ON (B)(6) 2024, THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL DEVICE ¿GETS HOT¿. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19166761 ↗
  • InjuryApr 22, 2024Overheating of Device; Overheating of Device

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE (B)(4), HALL ORALMAX ELITE HIGH SPEED DRILL WAS BEING USED ON APPROXIMATELY 01APR24 DATE WHEN IT WAS REPORTED ¿THE BRAND-NEW HANDPIECES WERE OVERHEATING. DR. CALLS ME AND IS SAYING IT IS HAPPENING AGAIN AND BURNT A PATIENT'S LIP. UNKNOWN WHICH ONE OR IF BOTH BURNED THE PATIENT.¿. FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED WITH NO ADDITIONAL INFORMATION FOUND. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO AN UNKNOWN DEGREE OF BURN.

    Patient problems: Burn(s)

    MAUDE report 19152927 ↗
  • InjuryApr 22, 2024Overheating of Device; Overheating of Device

    THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER, THAT THE PRO7000DE, HALL ORALMAX ELITE HIGH SPEED DRILL WAS BEING USED ON APPROXIMATELY (B)(6) 2024 DATE WHEN IT WAS REPORTED ¿THE BRAND-NEW HANDPIECES WERE OVERHEATING. DR. CALLS ME AND IS SAYING IT IS HAPPENING AGAIN AND BURNT A PATIENT'S LIP. UNKNOWN WHICH ONE OR IF BOTH BURNED THE PATIENT.¿ FURTHER ASSESSMENT WAS ATTEMPTED, AND A GOOD FAITH EFFORT WAS COMPLETED WITH NO ADDITIONAL INFORMATION FOUND. THERE WAS NO REPORT OF MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION TO THE PATIENT OR USER. THIS REPORT IS BEING RAISED ON THE REPORTED INJURY DUE TO AN UNKNOWN DEGREE OF BURN.

    Patient problems: Burn(s)

    MAUDE report 19152918 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.