Cavitron® 8161426Recalls & reported problems
Dentsply Professional · Cavitron® touch™ Package. Contains: Cavitron Touch™ Ultrasonic Scaling System, Steri-Mate® 360 Sterilizable, Detachable Handpieces, 30K Focused Spray® slimLINE® 10S Ultrasonic Insert - FITGRIP®, Redemption Form for Additional Ultrasonic Inserts, Cavitron Care Maintenance Plan Registration Information. · Class 2
- 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 D00381614261), received between Jun 24, 2024 and May 21, 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. How this data works · Data updated Oct 13, 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.
MalfunctionMay 21, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K STERI-MATE 360 TOUCH 1PACK IS ALLEGED TO GOT SO HOT, STEAMNG AND MELTED TO THE INSERT. PATIENT WAS NOT INVOLVED BUT A HYGIENIST HAND WAS BURNED. THE BURNED AREA WAS TREATED WITH POLYSPORIN.
Patient problems: Burn(s)
MAUDE report 22063876 ↗MalfunctionMay 16, 2025Overheating of Device; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON TOUCH G1000, THEY ALLEGE THAT THEY HANDPIECE AND THE INSERT TIP GET HOT. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22037305 ↗MalfunctionOct 23, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A CAVITRON TOUCH, 240V-UK, (B)(6) THAT WAS USED, IT IS ALLEGED THAT THE INSERTS GET VERY HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20513490 ↗MalfunctionJun 24, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT CAVITRON TOUCH PACKAGE-2015 IT IS ALLEGED THAT THE INSERT TIP ARE OVERHEATING EVEN WITH REPORTEDLY GOOD WATER FLOW. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19601081 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.