Midwest Tradition® 790344Recalls & reported problems
SIRONA Dental Systems GmbH · Midwest Tradition® TB · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI E2767903440), received between Apr 25, 2024 and Apr 23, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (5 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
Most reported problems
Device problems
- Overheating of Device5
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Burn(s)1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 23, 2026Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST HIGHSPEED TRADITION® HANDPIECE OVERHEATED. 1 EVENT RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24964086 ↗MalfunctionJan 20, 2026Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE MIDWEST TRADITION® TB HANDPIECES OVERHEATED. 1 EVENT RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24115906 ↗MalfunctionApr 22, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST TRADITION® TB HANDPIECE OVERHEATED. 1 EVENT RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21880822 ↗MalfunctionOct 23, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENTS WHERE A MIDWEST TRADITION® TB HANDPIECE OVERHEATED. 1 EVENT RESULTED IN THE PATIENT BEING SLIGHTLY BURNED WITH NO INTERVENTION.
Patient problems: Burn(s)
MAUDE report 20514193 ↗MalfunctionApr 25, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS. WHERE A MIDWEST TRADITION HANDPIECE OVERHEATED. 2 EVENTS RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19181039 ↗
Other Handpiece, Air-Powered, Dental devices
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- Midwest T1 Energo 6814680SIRONA Dental Systems GmbH · Handpiece, air-powered, dental14 reports
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- HENRY SCHEIN 5701072Henry Schein, Inc. · Handpiece, air-powered, dental11 reports
- Midwest® E mini 875101SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental10 reports
- Midwest® E Pro 875105SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental10 reports
- Maxima 5702094Henry Schein, Inc. · Handpiece, air-powered, dental8 reports
- Z890LNakanishi Inc. · Handpiece, air-powered, dental5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.