Midwest Stylus® Plus 792400Recalls & reported problems
SIRONA Dental Systems GmbH · Midwest Stylus® Plus SPM · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI E2767924000), received between Jan 22, 2024 and Oct 27, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (4 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.
Reports received per month
Most reported problems
Device problems
- Overheating of Device4
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Burn(s)1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 27, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST STYLUS® PLUS SPM HANDPIECE OVERHEATED. 1 EVENT RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23389456 ↗MalfunctionApr 22, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST STYLUS® PLUS SPM HANDPIECE OVERHEATED. 1 EVENT RESULTED IN DOCTOR BEING SLIGHTLY BURNED WITH NO INTERVENTION.
Patient problems: Burn(s)
MAUDE report 21880820 ↗MalfunctionJan 24, 2025Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 2 MALFUNCTION EVENTS WHERE A MIDWEST STYLUS® PLUS SPM HANDPIECE OVERHEATED. 2 EVENTS RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21232203 ↗MalfunctionJan 22, 2024Overheating of Device; Overheating of Device
THIS REPORT SUMMARIZES 1 MALFUNCTION EVENT WHERE A MIDWEST STYLUS PLUS HANDPIECE OVERHEATED. THE 1 EVENT RESULTED IN NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18556622 ↗
Other Handpiece, Air-Powered, Dental devices
- Henry Schein Maxima 5702660Henry Schein, Inc. · Handpiece, air-powered, dental15 reports
- Midwest T1 Energo 6814680SIRONA Dental Systems GmbH · Handpiece, air-powered, dental14 reports
- Midwest® E Plus 875205SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental12 reports
- 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
- Midwest Tradition® 790344SIRONA Dental Systems GmbH · Handpiece, Air-Powered, Dental5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- 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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