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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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 1 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 2 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 2 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 2 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

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

    THE TOOTHBRUSH CAUSED MY TEETH TO BREAK.

    Patient problems: Tooth Fracture

    MAUDE report 25177017 ↗
  • 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

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Sources and updates

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