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Hu-Friedy UI25SD10Recalls & reported problems

Hu-Friedy Mfg. CO., LLC · 10 Swivel Direct Flow, 25K · Class 2

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 10889950075361), received between May 7, 2019 and May 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

Most reported problems

Device problems

  • Break1

Patient problems

  • Foreign Body In Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryMay 7, 2019Break; Break

    THE DENTAL HYGIENIST WAS USING THE ULTRASONIC INSTRUMENTATION FOR A ROUTINE PREVENTIVE CARE APPOINTMENT. THE PATIENT HAD A SLIGHTLY CLOSED MOUTH AND THOUGHT HE SWALLOWED CALCULOUS BUT, IT WAS THE INSTRUMENT TIP. THE PATIENT WAS SENT TO THE EMERGENCY ROOM FOR X-RAYS AND AN 8MM PART OF THE TIP WAS FOUND IN HIS STOMACH. PATIENT WAS ADVISED TO GO BACK TO ER IF HE HAD ANY ADDITIONAL STOMACH PAIN OR FEVER.

    Patient problems: Foreign Body In Patient

    MAUDE report 8588530 ↗

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.