GUM® 3612 (REF RQ; RQW)Recalls & reported problems
Sunstar Americas, Inc. · PROXABRUSH GO-BETWEENS CLEANERS MODERATE · Class 1
All models of GUM (16)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00070942002462), received between Nov 13, 2024 and Jul 24, 2025 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Detachment of Device or Device Component2
- Break1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 24, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CONSUMER COMPLAINED THAT THE GO BETWEEN CLEANERS ARE MADE VERY FLIMSY NOW. SHE'S USED TIGHT AND MODERATE FOR YEARS AND HAS ALWAYS BEEN ABLE TO USE THEM FOR OVER A WEEK AND NOW THEY DON'T LAST MORE THAN 1 DAY. THE BRISTLES FELL OUT AND THE WIRE BROKE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22590612 ↗MalfunctionFeb 13, 2025Break; Break
CUSTOMER COMPLAINED WIRE BREAKS TOO EASILY AND THEY ONLY GET ONE USE OUT OF IT DURING A SESSION BEFORE THE WIRE BREAKS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21378861 ↗MalfunctionNov 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER CALLED TO LET US KNOW THAT THE WIRE KEEPS BREAKING AND SHE HAD TO USE 3 A WEEK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20680018 ↗
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® 871Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 3614Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL4 reports
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL3 reports
- GUM® 3612Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL2 reports
- GUM® 3614Sunstar 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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