GUM® 414Recalls & reported problems
Sunstar Americas, Inc. · PROXABRUSH REFILLS TIGHT · Class 1
All models of GUM (16)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00070942752763), received between May 14, 2026 and May 14, 2026 — classified as 1 malfunction.
The most frequently reported specific device problem is “Separation Problem” (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.
Reports received per month
Most reported problems
Device problems
- Separation Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 14, 2026Separation Problem
WAS USING PROXABRUSH REFILLS AND THE LATCH CAME UNDONE AND I SWALLOWED IT - I HAD TO GO TO THE HOSPITAL. I'VE MADE 7 OTHER COMPLAINTS ABOUT THIS IN THE PAST TO YOU GUYS BUT NOTHING HAS BEEN DONE. WHAT A COMPANY. YOU ALL DESERVE TO BE FIRED, NO WONDER YOUR RATINGS HAVE GONE DOWN OVER THE PAST YEARS. THE CHIEF EXECUTIVE OFFICER NEEDS TO BE FIRED, MANUFACTURING NEEDS TO BE FIRED, QUALITY ASSURANCE SHOULD BE FIRED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25175835 ↗
Other TOOTHBRUSH, MANUAL devices
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL19 reports
- GUM Technique Deep Clean 525Sunstar Americas, Inc. · Toothbrush, Manual9 reports
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL8 reports
- GUM® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 871Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 1614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL2 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.
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