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Hu-Friedy UI25SS10Recalls & reported problems

Hu-Friedy Mfg. CO., LLC · 10 Universal SWIVEL, 25k · Class 2

Data updated Oct 18, 2026 from official FDA records · Editorial policy

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 10889950075484), received between Dec 5, 2019 and Dec 5, 2019 — classified as 1 injury.

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

Most reported problems

Device problems

  • Material Fragmentation1

Patient problems

  • Bowel Perforation1

Recent adverse event reports

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

  • InjuryDec 5, 2019Material Fragmentation; Material Fragmentation

    DURING A DENTAL SCALING PROCEDURE THE SCALER TIP BROKE OFF (APPROX. 2CM BROKE OFF) AND WAS SWALLOWED. PATIENT WAS SENT TO A HOSPITAL AND AN X-RAY SCAN WAS PERFORMED AND REVEALED THAT THE SCALER TIP WAS INSIDE PATIENT. PATIENT WAS LATER ADMITTED TO THE HOSPITAL FOR OBSERVATION FOR 2 DAYS. PATIENT FOUND HIMSELF EXCRETING BLOOD IN LATE (B)(6) 2019. SUCH SYMPTOM CONTINUED OVER A COURSE OF FEW DAYS BEFORE SUBSIDING AND IT WAS SUSPECTED THAT THE BLOOD EXCRETION WAS DUE TO THE SCALER TIP PERFORATING THE LINING OF HIS BOWEL AND/ OR IRRITATING HIS PRIOR OPERATION SITE. PATIENT RETURNED ON (B)(6) 2019 FOR A FOLLOW UP SESSION AND WAS TOLD THAT THE SCALER TIP HAD LIKELY BEEN PASSED OUT NATURALLY AS THE TIP WAS NO LONGER FOUND IN HIS BODY.

    Patient problems: Bowel Perforation

    MAUDE report 9418237 ↗

Other Scaler, ultrasonic devices

All Scaler, ultrasonic devices →

Sources and updates

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