Hu-Friedy UI30SSXTRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · Swivel XT, 30k · Class 2
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889950075798), received between Oct 9, 2024 and May 26, 2026 — classified as 3 injuries.
The most frequently reported specific device problem is “Break” (3 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
- Break3
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
- Laceration(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 26, 2026Break; Material Fragmentation
DEVICE BROKE IN PATIENT'S MOUTH. A FLAP IN THE GUMS WAS MADE TO GET THE PIECE OUT.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 25280165 ↗InjuryFeb 11, 2025Break; Break
DURING A DENTAL PROCEDURE INSERT BROKE IN PATIENT MOUTH. CLINICIAN DID NOT FIND THE PIECE THAT BROKE OFF AND FEARED THE PATIENT MAY HAVE SWALLOWED IT. PATIENT WAS REFERRED TO EMERGENCY FACILITY TO GET X-RAYS DONE TO MAKE SURE THE PIECE WAS NOT SWALLOWED. PATIENT CONFIRMED NO PIECE WAS FOUND AFTER X-RAYS.
Patient problems: Foreign Body In Patient
MAUDE report 21357193 ↗InjuryOct 9, 2024Break; Break
THE USER FACILITY REPORTED THAT DURING A DENTAL CLEANING PROCEDURE THE TIP OF ULTRASONIC INSERT DETACHED FROM THE HANDPIECE AND IT SPLIT THE PATIENT LIP.
Patient problems: Laceration(s)
MAUDE report 20407860 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.