HENRY SCHEIN 5701073Recalls & reported problems
Henry Schein, Inc. · Maxima Pro 2L Highspeed Handpiece · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00304040090053), received between Jun 13, 2024 and Jun 27, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 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
- Detachment of Device or Device Component2
- Use of Device Problem2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 27, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
BUR ATTACHMENT FALLS OFF FROM DEVICE DURING TREATMENT. NO PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19630687 ↗InjuryJun 13, 2024Use of Device Problem; Detachment of Device or Device Component; Use of Device Problem; Detachment of Device or Device Component
BUR ATTACHMENT FALLS OFF FROM DEVICE DURING TREATMENT; NO PATIENT INJURIES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19530241 ↗
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- 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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