Cavitron® 80401Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI® 2-PK · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI D003804011), received between Dec 28, 2024 and Dec 28, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Overheating of Device” (1 report).
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 Device1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 28, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI (-10L/-10R) 2-PAK IS ALLEGED TO HAVE OVERHEATED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21031676 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.