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