DuraTip® DURA30-PSRecalls & reported problems
Parkell, Inc. · 30K DuraTip® Perio Slim Insert · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810000522903), received between Jun 27, 2025 and Jun 27, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Use of Device Problem1
Patient problems
- Laceration(s)1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 27, 2025Use of Device Problem; Improper or Incorrect Procedure or Method; Use of Device Problem; Improper or Incorrect Procedure or Method
ON MAY 30, 2025, WE BECAME AWARE OF AN ADVERSE EVENT INVOLVING A DENTAL HYGIENIST WITH OUR DURA30-PS 30K DURATIP® PERIO SLIM INSERT. THIS INSERT IS AN ACCESSORY TO OUR "TURBO" ULTRASONIC SCALER. WHILE ATTEMPTING TO REMOVE THE INSERT FROM THE HANDHELD SHE WAS POKED BY THE SHARP TIP OF THE INSERT. NEITHER THE DENTIST NOR THE HYGIENIST WILL SHARE INFORMATION OF THE EVENT AND POSSIBLE TREATMENT DUE TO "HIPPA" RESTRICTIONS. WE WERE NOT NOTIFIED OF THE EVENT NOR ANY TREATMENT IN A TIMELY MANNER. WE ARE FILING THIS REPORT WITH AN OVERABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). THE HYGIENIST DID NOT FOLLOW IFU PRECAUTIONS OR OPERATING INSTRUCTIONS AS BELOW: "PRECAUTIONS" - WHEN INSERTING THE INSERT INTO THE HANDPIECE, ALWAYS USE A TWISTING MOTION. "OPERATING INSTRUCTIONS" - 2. FILL THE HANDPIECE WITH WATER ACCORDING TO THE SCALER MANUFACTURER'S INSTRUCTIONS. 3. LUBRICATE THE O-RING WITH WATER. 4. GENTLY TWIST THE INSERT WHILE INSERTING IT INTO A HANDPIECE UNTIL IT IS FULLY SEATED. SHE DID NOT TWIST, NOR DID SHE LUBRICATE THE HANDHELD OR THE O-RING. WE WILL FILE A FOLLOW-UP REPORT IF WE BECOME AWARE OF ANY ADDITIONAL RELEVANT INFORMATION.
Patient problems: Laceration(s)
MAUDE report 22347209 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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