Cavitron® 80392Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® Ultrasonic Insert 25K FSI®-SLI®-10S · 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 D003803921), received between Mar 29, 2023 and Aug 4, 2025 — classified as 5 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
- No Flow3
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Burn(s)1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 25K FSI-SLI-10S INSERT,PKD ALLEGEDLY INSERT GETS HOT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22706808 ↗MalfunctionJul 17, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 25K FSI-SLI-10S INSERT, PKD TIP GOT REALLY HOT AND BURNED THE LIP OF A PATIENT. THE PATIENT REQUIRED NO MEDICAL ATTENTION.
Patient problems: Burn(s)
MAUDE report 19764748 ↗MalfunctionJan 23, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT 25K FSI-SLI-10S INSERT,PKD IT IS ALLEGED THAT WATER WOULD NOT FLOW OUT OF TIP AND TIP OVERHEATS; NO WATER FLOW THROUGH DEVICE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18562316 ↗MalfunctionAug 29, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 25K FSI-SLI-10S INSERT,PKD ALLEGEDLY HAS SPORADIC WATER FLOW AND GET HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17641661 ↗MalfunctionMar 29, 2023No Flow; No Flow
IN THIS EVENT IT IS REPORTED THAT A 25K FSI-SLI-10S INSERT, PKD DURING USE WATER WOULD NOT FLOW OUT OF INSERT AND THE INSERT IS HEATING UP. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16637180 ↗
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.