Cavitron® 8250001Recalls & reported problems
Dentsply Professional · Cavitron® touch™ Ultrasonic Scaler and Cavitron® Handpiece 115V-DOM · Class 2
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI D00382500011), received between Jan 23, 2025 and Jan 7, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Restricted Flow rate” (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
- Restricted Flow rate4
- Overheating of Device3
- No Flow1
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 7, 2026Restricted Flow rate; Overheating of Device
WHILE THE CUSTOMER WAS USING A CAVITRON TOUCH 115V DOM G1000 THEY ALLEGE THAT THE HANDPIECE AND INSERT TIP ARE WARM TO THE TOUCH. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23990652 ↗MalfunctionDec 9, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A CAVITRON TOUCH, 240V-UK, G1000 HAD THE INSERT TIPS GET HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23758290 ↗MalfunctionJun 6, 2025Restricted Flow rate; Restricted Flow rate
IN THIS EVENT IT IS REPORTED THAT A CAVITRON TOUCH,240V-UK,G1000 HAD INTERMITTENT WATER FLOW AND THE HANDPIECE HEATS UP. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22160929 ↗MalfunctionApr 28, 2025Restricted Flow rate; Overheating of Device; Restricted Flow rate; Overheating of Device
WHILE USING A CAVITRON TOUCH G1000 THEY ALLEGE THAT THEY ARE HAVING WATER PRESSURE ISSUES AND THE HANDPIECE IS HEATING UP, NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21917924 ↗MalfunctionJan 23, 2025Restricted Flow rate; No Flow; Restricted Flow rate; No Flow
WHILE USING A CAVITRON TOUCH G1000 THEY ALLEGE THAT THEY HAVE NO WATER AND THE HANDPIECE AND INSERT TIPS ARE GETTING HOT; NO INJURY RESULTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21217427 ↗
Other Scaler, ultrasonic devices
- AIR-FLOW FT-230-2B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.