DuraTip® DURA30-USRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810000522927), received between Oct 28, 2025 and Apr 6, 2026 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Handling Problem” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2026Material Fragmentation; No Apparent Adverse Event; Device Handling Problem

  PARKELL, INC. BECAME AWARE OF AN INCIDENT INVOLVING A PARKELL INSERT, THE DURA30-US, ON MARCH 9, 2026. THE INSERT WAS IN USE BY A STUDENT WHEN IT BROKE OFF IN A PATIENT'S MOUTH. IT WAS CAUGHT IN THE TRAP AND IMMEDIATELY SUCTIONED OUT. NO INJURY WAS INITIALLY REPORTED. NO TREATMENT WAS SOUGHT. IMAGES OF THE INSERT WERE PROVIDED FOR EVALUATION. THE INSERT WAS RETURNED WITHOUT THE TIP. THE INSERT IS PART OF THE STUDENT INSTRUMENT PACKAGE. AS PART OF THE RESOLUTION, THE HYGIENE COORDINATOR AT THE UNIVERSITY WAS INSTRUCTED TO REMIND CLINICAL STUDENTS TO ADHERE TO THE PERFORMANCE GUIDE TO ENSURE PROPER DEVICE HANDLING AND USAGE PARAMETERS, MINIMIZING THE RISK OF MECHANICAL FATIGUE OR BREAKAGE. WE ARE FILLING THIS REPORT IN AN ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). WE WILL FILE A FOLLOW-UP REPORT IF WE BECOME AWARE OF ANY ADDITIONAL RELEVANT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24794385 ↗
• MalfunctionDec 16, 2025Fracture; Fracture

  ON (B)(6) 2025, WE RECEIVED A COMPLAINT INVOLVING OUR DURA30-US INSERT. THIS INSERT IS AN ACCESSORY TO OUR "TURBO" ULTRASONIC SCALER. INITIAL COMPLAINT INDICATED THAT THE TIP BROKE. SUBSEQUENTLY WE DISCOVERED THAT, UPON INITIATION OF PROCEDURE, THE INSERT TIP BROKE IN THE PATIENT'S MOUTH. THERE WAS NO INJURY TO EITHER THE HYGIENIST OR THE PATIENT. THE TIP WAS IMMEDIATELY RECOVERED. THE INSERT WAS RETURNED FOR EVALUATION MINUS THE BROKEN TIP. THE INSERT IS UNDER EVALUATION. WE ARE FILING THIS REPORT WITH AN OVERABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23815789 ↗
• MalfunctionOct 28, 2025Material Fragmentation; No Apparent Adverse Event; Device Handling Problem; Material Fragmentation; No Apparent Adverse Event; Device Handling Problem

  ON OCTOBER 10TH, 2025, PARKELL BECAME AWARE OF AN INCIDENT INVOLVING OUR INSERT, DURA30-US - DURATIP® 30K UNIVERSAL SLIM INSERT. THIS INSERT IS AN ACCESSORY TO OUR TURBO ULTRASONIC SCALER. THE INSERT WAS IN USE BY A DENTAL STUDENT WHEN IT BROKE OFF IN THE PATIENT'S MOUTH. NO INJURY WAS INITIALLY REPORTED. NO TREATMENT WAS SOUGHT. THE UNIVERSITY IS KEEPING THE INSERT AND WILL NOT RETURN IT FOR EVALUATION. WE HAVE RECEIVED IMAGES OF THE INSERT BOTH ALONE AND IN OUR PERFORMANCE GUIDELINE TOOL. EVALUATING THESE IMAGES, IT IS OUR EXPERT OPINION THAT THE INSERT WAS USED BEYOND PERFORMANCE GUIDELINE REQUIREMENT OF 3 MM OF WEAR. IFU INSTRUCTION FOR PERFORMANCE GUIDELINE - IF THE END OF THE TIP DOES NOT EXTEND FULLY ACROSS THE 3 MM INDICATOR GROOVE (FIGURE 4) OR IS FLUSH WITH THE LEFT SIDE OF THE GROOVE, OR IS SHORT OF THE GROOVE, THE TIP HAS REACHED 3 MM OF WEAR AND SHOULD BE REMOVED FROM SERVICE AND REPLACED. WE ARE FILLING THIS REPORT IN AN ABUNDANCE OF CAUTION TO COMPLY WITH 21 CFR 803.10(C). WE WILL FILE A FOLLOW-UP REPORT IF WE BECOME AWARE OF ANY ADDITIONAL RELEVANT INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23401745 ↗