Hu-Friedy UI30SDLRecalls & reported problems
Hu-Friedy Mfg. CO., LLC · AF Swivel Direct Flow Left 30K · Class 2
Data updated Oct 16, 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 10889950075644), received between May 13, 2019 and May 13, 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 16, 2026.
Most reported problems
Device problems
- Material Fragmentation1
Patient problems
- Device Embedded In Tissue or Plaque1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2019Material Fragmentation; Material Fragmentation
A DENTAL HYGIENIST WAS PERFORMING PERIO MAINTENANCE WHEN AN INSTRUMENT TIP BROKE IN THE PATIENTS MOUTH AND WAS INGESTED. THE PATIENT WAS ADVISED TO GO TO THE HOSPITAL WHERE IMAGES WERE TAKEN. THE TIP WAS FOUND IN THE DESCENDING COLON BUT, NO SIGNS OF PERFORATION. THE SURGICAL TEAM DECIDED NOT TO OPERATE AND WAIT FOR THE TIP TO PASS.
Patient problems: Device Embedded In Tissue or Plaque
MAUDE report 8605797 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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