Hu-Friedy UI30SD1000Recalls & reported problems
Hu-Friedy Mfg. CO., LLC · 1000 Triple Bend Swivel Direct Flow 30k · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10889950075637), received between Jun 20, 2019 and May 27, 2025 — classified as 2 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break2
- Ejection Problem1
Patient problems
- Foreign Body In Patient1
- Needle Stick/Puncture1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 27, 2025Break; Break
USER FACILITY REPORTED THAT INSERT BROKE DURING CLEANING. PATIENT WENT FOR X-RAYS. X-RAYS WERE NEGATIVE.
Patient problems: Foreign Body In Patient
MAUDE report 22088174 ↗MalfunctionJun 27, 2024Break; Break
THE USER FACILITY REPORTED THAT THE TIP OF THEIR 1000 TRIPLE BEND SWIVEL DIRECT FLOW ULTRASONIC INSERT WAS DAMAGED DURING A DENTAL PROCEDURE AND THE TIP WAS UNABLE TO BE LOCATED. NO INJURY. THE PATIENT WAS SENT TO RECEIVE A CHEST X-RAY. NO SIGNIFICANT FINDINGS OF CHEST X-RAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19625137 ↗InjuryJun 20, 2019Ejection Problem; Ejection Problem
AN EMPLOYEE WAS TAKING OFF A CAVITRON INSERT AND THE RUBBER CAP SLIPPED OFF CAUSING HER HAND TO COME IN CONTACT WITH THE END OF THE INSERT WHICH, NICKED HER RIGHT FINGER.
Patient problems: Needle Stick/Puncture
MAUDE report 8719516 ↗
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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.
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