Hu-Friedy UI30SD100Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10889950075620), received between Jan 14, 2019 and Apr 3, 2025 — classified as 5 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 3, 2025Break; Break

  DEALER/DISTRIBUTOR REPORTED INSERT BROKE OFF IN PATIENT'S MOUTH DURING PROCEDURE. TIP WENT TO BACK OF PATIENT'S THROAT, UNCLEAR IF SWALLOWED. PATIENT WAS SENT TO URGENT CARE.

  Patient problems: Foreign Body In Patient

  MAUDE report 21767737 ↗
• InjuryDec 12, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A DENTAL PROCEDURE THE TIP OF ULTRASONIC INSERT BROKE IN PATIENT'S MOUTH. THE PATIENT SWALLOWED THE TIP AND WAS SENT TO THE ER FOR EVALUATION. THE HOSPITAL RELEASED THE PATIENT AND THE BROKEN END OF THE MATERIAL THAT WAS SWALLOWED DID PASS THROUGH BOWEL MOVEMENTS. NO MEDICAL SURGERY OR OTHER INTERVENTIONS WERE REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20914286 ↗
• InjuryDec 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  USER FACILITY REPORTED THAT THE INSERT HAD JUST BEEN PURCHASED AND BURNED THE USER'S HAND.

  Patient problems: Burn(s)

  MAUDE report 20836711 ↗
• MalfunctionMay 16, 2024Break; Break

  THE USER FACILITY REPORTED THAT DURING A DENTAL PROCEDURE THE TIP OF THEIR THIN SWIVEL DIRECT FLOW DETACHED IN THE PATIENT'S MOUTH RESULTING IN THEM SWALLOWING IT. THERE WAS NO REPORT OF PATIENT HARM. THE PATIENT SUBSEQUENTLY SAW A PHYSICIAN AND THE TIP WAS FOUND IN THE PATIENT'S STOMACH. IT IS UNKNOWN IF ANY MEDICAL TREATMENT WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19332834 ↗
• MalfunctionMay 8, 2024Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THEIR SWIVEL DIRECT FLOW ULTRASONIC INSERT DETACHED IN THE PATIENT'S MOUTH DURING A DENTAL PROCEDURES. IT WAS REPORTED THAT THE PATIENT WAS SENT TO RECEIVE A CHEST X-RAY. THE CHEST X-RAY CONFIRMED THAT NO PIECE OF THE INSERT WAS PRESENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19274233 ↗
• MalfunctionMay 12, 2022Break; Break

  THE USER FACILITY REPORTED THAT THE TIP OF THEIR SWIVEL DIRECT FLOW ULTRASONIC INSERT DETACHED IN THE PATIENT'S MOUTH DURING A DENTAL PROCEDURE AND THE PATIENT SWALLOWED THE TIP. IT WAS REPORTED THAT THE PATIENT WAS SENT TO RECEIVE X-RAYS.

  Patient problems: Insufficient Information

  MAUDE report 14379965 ↗
• InjuryJun 20, 2019Material Fragmentation; Material Fragmentation

  DURING A SCALING AND ROOT PLANING (SRP) PROCEDURE, THE TIP OF AN INSTRUMENT BROKE IN A PATIENT'S MOUTH AND WAS SWALLOWED. THE PATIENT WAS REFERRED TO THE ER AND IT WAS REPORTED TO IMAGE DENTAL THAT THE PATIENT WAS EXAMINED AND TOLD THE TIP WOULD PASS ON ITS OWN.

  Patient problems: Foreign Body In Patient

  MAUDE report 8719305 ↗
• InjuryJan 14, 2019Material Fragmentation; Material Fragmentation

  DURING A DENTAL CLEANING THE TIP OF AN INSTRUMENT BROKE OFF IN THE PATIENT'S MOUTH AND COULD NOT BE LOCATED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8246458 ↗