Cavitron® 82007Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® FITGRIP® Ultrasonic Insert 30K FSI®-SLI®-10R FG · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI D003820071), received between Nov 2, 2023 and Feb 20, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (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
- Overheating of Device2
- No Flow1
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.
MalfunctionFeb 20, 2026Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-FG-10R INS, PKD IS ALLEGED TO HAVE NO WATER FLOW AND THE TIP BECAME EXTREMELY HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24401824 ↗MalfunctionNov 2, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-FG-10R INS,PKD GETS HOT DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18054639 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.