Cavitron® 8161429Recalls & reported problems
Dentsply Professional · Cavitron® 300 Series Package, 115V Domestic Ultrasonic Scaler · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI D00381614291), received between Sep 24, 2024 and Apr 27, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “No Flow” (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
- No Flow5
- Overheating of Device3
- Restricted Flow rate1
Patient problems
- No Clinical Signs, Symptoms or Conditions8
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 27, 2026No Flow
WHILE USING A G310 THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE INSERT IS HEATING UP. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25001094 ↗MalfunctionApr 16, 2026No Flow
WHILE USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE IS GETTING WARM TO THE TOUCH, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24896541 ↗MalfunctionApr 3, 2026Restricted Flow rate; No Flow
WHILE USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THE HANDPIECE IS HEATING UP AND THEY HAVE LOW WATER FLOW, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775096 ↗MalfunctionMar 24, 2026No Flow
WHILE USING A CAVITRON 300 SERIES G310, THEY ALLEGE THAT THE FACE PLATE IS GETTING HOT AND THEY HAVE NO WATER TO THE STERIMATE.; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680415 ↗MalfunctionJan 14, 2026No Flow
WHILE USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE IS GETTING WARM, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067456 ↗MalfunctionDec 28, 2025Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON 300 SERIES G310 THEY ALLEGE THAT THE INSERT GETS HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23903721 ↗MalfunctionJun 23, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A CAVITRON 300 SERIES PACKAGE ALLEGEDLY THE STERIMATE AND INSERT WERE HEATING UP DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22307557 ↗MalfunctionSep 24, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT CAVITRON 300 SERIES PACKAGE, IT IS ALLEGED THAT THE UNIT ALWAYS SEEMS TO HEAT UP , WITH TIP AND STERIMATE GETTING HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20293707 ↗
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- AIR-FLOW-PIEZON FT-229HF-0B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- Cavitron® 81302Dentsply Professional · Scaler, ultrasonic67 reports
- Posterior CleanFlow Procedure Instrument with Matrices FG-013-00004Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- APM Procedure Instrument with Matrix FG-003-00011Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- Cavitron® 8184001Dentsply Professional · Scaler, ultrasonic49 reports
- Cavitron® 8161425Dentsply Professional · Scaler, ultrasonic45 reports
- Cavitron® 80395Dentsply Professional · Scaler, ultrasonic36 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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