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
- AIR-FLOW-PIEZON FT-229HF-0B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- AIR-FLOW FT-230-2B-302E.M.S. Electro Medical Systems S.A. · Scaler, Ultrasonic3 recalls0 reports
- Cavitron® 81302Dentsply Professional · Scaler, ultrasonic67 reports
- APM Procedure Instrument with Matrix FG-003-00011Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- Posterior CleanFlow Procedure Instrument with Matrices FG-013-00004Sonendo, Inc. · Scaler, Ultrasonic1 recall0 reports
- Cavitron® 8184001Dentsply Professional · Scaler, ultrasonic49 reports
- Cavitron® 8161425Dentsply Professional · Scaler, ultrasonic45 reports
- Cavitron® 80395Dentsply Professional · Scaler, ultrasonic36 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page