Cavitron® 8161425Recalls & reported problems
Dentsply Professional · Cavitron® plus Package. Also contains: Cavitron Plus Ultrasonic Scaler, Steri-Mate® Sterilizable Detachable Handpiece, 30K Focused Spray® slimLINE® 10S Ultrasonic Insert - FITGRIP®, Redemption Form for Additional Ultrasonic Inserts, Cavitron Care Maintenance Plan Registration Information. · Class 2
Quick summary
This Dentsply Cavitron Plus ultrasonic scaler package is used for dental scaling. The 45 reports mostly describe the handpiece and tips heating up during use, often alongside no water flow or reduced water flow. No deaths and no injuries were reported, though two reports mention burns. There are no recalls naming this device.
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
- 45
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI D00381614251), received between Sep 6, 2023 and Jun 17, 2026 — classified as 45 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (25 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 Device25
- No Flow22
- Restricted Flow rate11
Patient problems
- No Clinical Signs, Symptoms or Conditions44
- Burn(s)2
Recent adverse event reports
The 25 most recent of 45 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 17, 2026Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON PLUS PACKAGE-2015, THEY ALLEGE THAT "CUSTOMER CLAIMS THAT CAVITRON TIPS HEAT UP.". NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25536599 ↗MalfunctionJun 8, 2026Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A CAVITRON PLUS PACKAGE-2015 OVERHEATED AND THE TIPS GOT HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25433737 ↗MalfunctionMay 1, 2026Overheating of Device; No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE NO WATER AND THE INSERT TIP IS GETTING HOT; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25056932 ↗MalfunctionApr 3, 2026Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON PLUS G136, THEY ALLEGE THAT THE HANDPIECE AND THE INSERT IS HEATING UP. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24775097 ↗MalfunctionMar 24, 2026No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24680651 ↗MalfunctionMar 19, 2026No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE IS GETTING HOT; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24640536 ↗MalfunctionMar 4, 2026Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A CAVITRON PLUS PACKAGE-2015 IS ALLEGED THE INSERTS GET HOT DURING USE, THIS OCCURS WITH MULTIPLE INSERTS. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24513333 ↗MalfunctionMay 27, 2025No Flow; No Flow
WHILE USING A CAVITRON PLUS G136 THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS HEATING UP; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22089082 ↗MalfunctionMay 14, 2025No Flow; No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS GETTING HOT, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22018344 ↗MalfunctionMay 14, 2025No Flow; No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22018342 ↗MalfunctionApr 28, 2025Restricted Flow rate; No Flow; Restricted Flow rate; No Flow
WHILE USING A CAVITRON PLUS G136 THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS HEATING UP NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917922 ↗MalfunctionMar 31, 2025No Flow; No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THE HANDPIECE IS HEATING UP AND THEY HAVE NO WATER FLOW, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21731153 ↗MalfunctionMar 11, 2025Restricted Flow rate; Restricted Flow rate
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THE WATER STOPS DURING USE AND THE HANDPIECE IS HEATING UP; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21571750 ↗MalfunctionFeb 25, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21462949 ↗MalfunctionFeb 18, 2025Restricted Flow rate; Overheating of Device; No Flow; Restricted Flow rate; Overheating of Device; No Flow
WHILE THE CUSTOMER WAS USING A CAVITRON PLUS G136, THEY ALLEGE THAT LOW WATER FLOW AND THE TIP IS GETTING WARM. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21401285 ↗MalfunctionFeb 3, 2025Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON PLUS G136 THEY ALLEGE THAT THE INSERTS ARE HEATING UP. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21298468 ↗MalfunctionJan 24, 2025Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON PLUS G136 THEY ALLEGE THAT THE INSERT GOT HOT AND BURNT THE PATIENT. OINTMENT WAS APPLIED TO PATIENT'S LIP.
Patient problems: Burn(s)
MAUDE report 21233301 ↗MalfunctionJan 15, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT CAVITRON PLUS TAP-ON,240V-UK-G136 IS ALLEGED TO HAVE POOR WATER FLOW TO INSERT CAUSING IT TO OVERHEAT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21157458 ↗MalfunctionDec 10, 2024No Flow; No Flow
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE NO WATER FLOW AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20891982 ↗MalfunctionDec 3, 2024Restricted Flow rate; No Flow; Restricted Flow rate; No Flow
WHILE USING A CAVITRON PLUS G136 THEY ALLEGE THAT THEY HAVE LOW WATER FLOW AND THE HANDPIECE OVER HEATS, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20835389 ↗MalfunctionNov 20, 2024Restricted Flow rate; Restricted Flow rate
WHILE USING A CAVITRON PLUS G136, THEY ALLEGE THAT THEY HAVE LACK OF WATER FLOW AND THE HANDPIECE IS OVERHEATING, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20735935 ↗MalfunctionOct 25, 2024Restricted Flow rate; No Flow; Restricted Flow rate; No Flow
WHILE USING A CAVITRON PLUS G136 THEY ALLEGE THAT THE HANDPIECE IS HEATING UP AND THEY HAVE NO WATER FLOW, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20535296 ↗MalfunctionOct 21, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT CAVITRON PLUS PACKAGE-2015 ALLEGEDLY HAS NO WATER FLOW AND THE INSERT HEATS UP. NO INJURY ALLEGEDLY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20494743 ↗MalfunctionOct 11, 2024No Flow; No Flow
WHILE USING A CAVITRON PLUS G136 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE IS GETTING HOT, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20428876 ↗MalfunctionOct 2, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
WHILE USING A CAVITRON PLUS G136 THEY ALLEGE THAT THEY ARE HAVING NO WATER FLOW AND OVERHEATING. NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20353033 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.