GUM Technique Deep Clean 525Recalls & reported problems
Sunstar Americas, Inc. · GUM Technique Deep Clean Compact Toothbrush · Class 1
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 9
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00070942008112), received between Jul 23, 2025 and Aug 4, 2026 — classified as 2 injuries, 7 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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
- Detachment of Device or Device Component3
- Material Separation3
- Adverse Event Without Identified Device or Use Problem1
- Break1
- Material Integrity Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions7
- Choking1
- Pain1
- Sore Throat1
- Tooth Fracture1
- Vomiting1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 4, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50133347 ↗MalfunctionJun 8, 2026Material Separation
HI (B)(6). HOPE ALL IS WELL. I WAS JUST MADE AWARE THAT SEVERAL PATIENTS HAVE NOTIFIED OUR FRONT DESK STAFF THAT BRISTLES FROM THE TOOTHBRUSHES THEY HAVE BEEN USING HAVE COME OFF AND BECOME LODGED IN THEIR TEETH. IN ONE CASE IT GOT STUCK IN AN ELDERLY PATIENT¿S THROAT. PLEASE CHECK ON YOUR END IF THERE HAVE BEEN ANY CHANGES IN THE PRODUCTION OF THE TOOTHBRUSHES. JUST WANT TO PREVENT ANY FURTHER ISSUES FOR ANYONE. NO SERIOUS INJURIES HAVE BEEN REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25428691 ↗MalfunctionMay 20, 2026Break
MY TOOTHBRUSH SNAPPED IN HALF DURING NORMAL USE HAS USED THE TOOTHBRUSH LIKE TWICE. STATES THIS IS THE SECOND TIME THAT THIS HAS HAPPENED WITH THIS BRUSH TYPE. (NO HARM CAUSE REPLACEMENT AND RETURN ENVELOPE (B)(6) 2026). RECEIVED RESPONSE (B)(6) 2026 THAT SHE HAS RECEIVED THE REPLACEMENT BRUSH BUT SHE HAD THREW OUT THE TOOTHBRUSH AFTER SENDING PHOTO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25237213 ↗InjuryMay 14, 2026Adverse Event Without Identified Device or Use Problem
MalfunctionFeb 24, 2026Material Integrity Problem
BRISTLES ARE FALLING OUT OF THE TOOTHBRUSH AND INTO HER MOUTH, NO HARM WAS CAUSED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434719 ↗MalfunctionFeb 24, 2026Material Separation
I HAVE BEEN USING GUM TOOTHBRUSHES CONSISTENTLY FOR YEARS. THE LAST FEW I HAVE USED, HOWEVER, ARE CONSTANTLY LOSING BRISTLES WHILE I'VE BEEN BRUSHING. THESE ARE BRUSHES THAT I HAVE BULK PURCHASED ON AMAZON, BOUGHT SINGLY AT PHARMACIES OR HAVE BEEN GIVEN TO ME BY MY DENTIST.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434683 ↗InjuryNov 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER USED BRUSH AND BRISTLES CAME OUT IN THEIR MOUTH CAUSING THEM TO CHOKE AND VOMIT. THEIR PARTNER HELPED THEM AS BRISTLES GOT CAUGHT IN THEIR MOUTH AND HELPED HER RINSE HER MOUTH. CUSTOMER VISITED DOCTOR DUE TO HAVING A VERY IRRITATED THROAT AND HAVE BEEN PRESCRIBED A BENZYDAMINE MOUTH WASH FOR THE PAIN AND INFLAMMATION.
Patient problems: Choking; Pain; Sore Throat; Vomiting
MAUDE report 23659776 ↗MalfunctionNov 12, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
CUSTOMER COMPLAINED THAT THE BRUSH LOSES ITS BRISTLES WHEN USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23537859 ↗MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
THERE WAS AN EMAIL THIS MORNING FROM STEPHANIE KIEFER¿S OFFICE REGARDING PATIENT FEEDBACK ON THE 525 TECH DEEP CLEAN COMPACT SOFT TOOTHBRUSH. THEY MENTIONED THAT THE BRISTLES HAVE BEEN FALLING OUT WHILE PATIENTS ARE BRUSHING THEIR TEETH.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22581871 ↗
Other Toothbrush, Manual devices
- GUM® 872Sunstar Americas, Inc. · TOOTHBRUSH, MANUAL19 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
- 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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