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Hu-Friedy UI30SD10Recalls & reported problems

Hu-Friedy Mfg. CO., LLC · 10 Swivel Direct Flow 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 10889950075613), received between Jul 3, 2019 and Nov 18, 2025 — classified as 3 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component1
  • Ejection Problem1
  • Material Fragmentation1

Patient problems

  • Foreign Body In Patient1
  • Laceration(s)1
  • Needle Stick/Puncture1

Recent adverse event reports

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

  • InjuryNov 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER CALLED IN STATING THEY WERE USING AN ULTRASONIC INSERT IN THEIR DENTSPLY CAVITON STERI MATE 360 - WHEN ATTEMPTING TO REMOVE INSERT FROM HANDPIECE, THE INSERT WAS STUCK. ATTEMPTED SEVERAL TIMES TO REMOVE, HOWEVER, RESULTED IN DOCTOR AND HYGIENIST CUTTING THEMSELVES DURING ATTEMPT.

    Patient problems: Laceration(s)

    MAUDE report 23588068 ↗
  • InjuryAug 23, 2019Ejection Problem; Ejection Problem

    AN INSERT WAS BEING REMOVED FROM HAND PIECE PRIOR TO SUBGINGIVAL DEBRIDEMENT. IT WAS VERY DIFFICULT TO REMOVE THEREFORE, THE HYGIENISTS HAND SLIPPED AND WAS CUT BY THE TIP OF THE INSERT.

    Patient problems: Needle Stick/Puncture

    MAUDE report 8925688 ↗
  • InjuryJul 3, 2019Material Fragmentation; Material Fragmentation

    DURING A DENTAL CLEANING THE TIP OF AN INSERT BROKE IN THE PATIENT'S MOUTH. THE PATIENT WAS SENT TO HOSPITAL FOR AN X-RAY AND A 2MM PIECE WAS FOUND IN HIS ABDOMEN. PATIENT WAS TOLD TO LET THE PIECE PASS AND NO ADDITIONAL TREATMENT WAS NECESSARY.

    Patient problems: Foreign Body In Patient

    MAUDE report 8758466 ↗

Other Scaler, ultrasonic devices

All Scaler, ultrasonic devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.