Cavitron® 81570Recalls & reported problems
Dentsply Professional · FOCUSED SPRAY® slimLINE® Ultrasonic Insert 30K FSI®-SLI®-1000 · Class 2
- Adverse event reports
- 23
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI D003815701), received between Apr 14, 2023 and Feb 6, 2026 — classified as 23 malfunctions.
The most frequently reported specific device problem is “Overheating of Device” (22 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 Device22
- No Flow3
Patient problems
- No Clinical Signs, Symptoms or Conditions22
- Burning Sensation1
Recent adverse event reports
The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 6, 2026Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD WAS DISCOVERED UPON OPENING THE PACKAGE THAT THE INSERTS STEM WAS BENT AT THE END. THE USER TRIED USING THE INSERT AND DURING USE THE NOZZLE BECOME HOTTER THAN NORMAL EVEN WITH INCREASED WATER FLOW. REPORTEDLY, NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24279139 ↗MalfunctionOct 15, 2025Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD ALLEGED TO HAVE NO WATER SPRAY AND THE TIP GETTING HOT. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23285056 ↗MalfunctionSep 11, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT, PKD IT IS ALLEGED THE INSERT IS LEAKING AND GETS REALLY HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23025432 ↗MalfunctionAug 4, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT, PKD ALLEGEDLY OVERHEATED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22697963 ↗MalfunctionJul 30, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD IS ALLEGED TO HAVE OVERHEATED DURING USE. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22668629 ↗MalfunctionApr 23, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD GOT HOT AND OVERHEATED. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21890036 ↗MalfunctionApr 23, 2025Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD OVERHEATS AND HAS WATER FLOW ISSUE. REPORTEDLY, NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21889993 ↗MalfunctionOct 10, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD THAT WAS BEING USED BY THE CUSTOMER ALLEGEDLY BURNED THE HYGIENIST. THEY HAD GRABBED THE DEVICE AND THE TIP WAS STILL HOT AND BURNT THEIR HAND AND FINGER. THE STACK WAS VERY WARPED AND THE WATER LEVEL WAS TURNED TO A LOW SETTING. THE HYGIENIST DID NOT NEED ANY MEDICAL ATTENTION.
Patient problems: Burning Sensation
MAUDE report 20416841 ↗MalfunctionSep 17, 2024Overheating of Device; No Flow; Overheating of Device; No Flow
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD WILL NOT SPRAY ANY WATER, HEATS UP AND GETS HOT. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20235493 ↗MalfunctionAug 20, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD ALLEGEDLY OVERHEATED. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20004499 ↗MalfunctionJul 22, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT, PKD ALLEGEDLY OVERHEATED DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19800730 ↗MalfunctionJul 22, 2024Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19800528 ↗MalfunctionDec 11, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD GOT HOT DURING USE AND WAS NOT WORKING AS IT SHOULD. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18302629 ↗MalfunctionOct 31, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD INSERT GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18038095 ↗MalfunctionOct 24, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT, PKD HEATS UP DURING USE AND SPRAYING TOO MUCH WATER. NO INJURY FROM ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17994535 ↗MalfunctionOct 18, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD GOT VERY HOT AND WAS NOT WORKING CORRECTLY. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17961388 ↗MalfunctionSep 18, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD ALLEGEDLY GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17763754 ↗MalfunctionJun 29, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD ALLEGEDLY GOT HOT DURING USE. NO INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17226256 ↗MalfunctionJun 21, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD GOT HOT DURING USE. NO INJURY REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17171551 ↗MalfunctionJun 21, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT A 30K FSI-SLI-1000 INSERT,PKD GOT HOT DURING USE. NO INJURY WAS REPORTED FROM THE ALLEGED EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17169672 ↗MalfunctionJun 5, 2023No Flow; No Flow
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD HAS NO WATER FLOW AND GETS HOT. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17059381 ↗MalfunctionApr 14, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT,PKD OVERHEATS DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16742016 ↗MalfunctionApr 14, 2023Overheating of Device; Overheating of Device
IN THIS EVENT IT IS REPORTED THAT 30K FSI-SLI-1000 INSERT, PKD GOT HOT DURING USE. NO INJURY OCCURRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16741945 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.