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GUM® 872 (REF RQ; RQW)Recalls & reported problems

Sunstar Americas, Inc. · PROXABRUSH GO BETWEENS CLEANERS TIGHT · Class 1

All models of GUM (16)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
19
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00070942002448), received between Oct 8, 2024 and Apr 17, 2026 — classified as 19 malfunctions.

The most frequently reported specific device problem is “Break” (12 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

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: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 4 reportsAug 2025: 2 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 1 reportsJan 2026: 3 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 2 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break12
  • Detachment of Device or Device Component5
  • Material Separation2

Patient problems

  • No Clinical Signs, Symptoms or Conditions19

Recent adverse event reports

The 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 17, 2026Break

    ON (B)(6) 2026: THE WIRE BRUSH FROM A GREEN HANDLED BRUSH DISLODGED FROM THE HOLDER AND STUCK IN MY TEETH. IT MAY STILL BE INSIDE MY THROAT OR ESOPHAGUS. I AM PURSUING MEDICAL ADVICE WHAT TO DO. ON (B)(6) 2026: YOU'RE SAYING IT IS SAFE TO SWALLOW A 3/4¿ LONG PIECE OF TWISTED STAINLESS-STEEL WIRE!? I HOPE! BECAUSE I¿M AFRAID IT WILL BECOME LODGED INSIDE IF I¿VE SWALLOWED IT. IF SO, I CAN ONLY HOPE IT PASSES WITHOUT HARM. I MESSAGED MY DOCTOR FOR HER ADVICE. THIS WAS NOT THE TIGHT SIZE. IT¿S THE MEDIUM GREEN ONES AND THIS WAS NOT THE FIRST TIME ONE HAD COME OUT THE RUBBER HANDLE. THE PRIOR TIMES, I WAS ABLE TO REMOVE THE BRUSH PART FROM MY GUMS AND MOUTH WITH MY FINGERS. I TRIED YOUR TIGHT SIZE BRUSHES AND FOUND THE CUT AND TWIST OF THE END WIRES FLARED AND WERE DIFFICULT TO GET BETWEEN MY TEETH, NOT MUCH NARROWER THAN THE GREEN MEDIUM ONES. I STARTED TO REPORT THIS, BUT I LET IT GO AND PURCHASED OTHERS. THE BRUSH IS PULLING OUT BECAUSE THERE IS NOTHING TO PREVENT IT, LIKE A BENT BASE OF THE WIRE IN THE HOLDER. I WOULD NOT WANT REPLACEMENT PRODUCT. I BELIEVE IT WOULD HAPPEN AGAIN. ON (B)(6) 2026: AFTER CLOSER LOOK, THE WIRE BROKE AT THE HANDLE, WHICH WOULD HAVE BEEN A MINIMAL LENGTH

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24918386 ↗
  • MalfunctionApr 15, 2026Material Separation

    SHE HAS BEEN USING 3614 GO BETWEEN WIDE FOR YEARS. LATELY WHEN SHE IS USING THEM THE BRISTLES ARE FALLING OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24887984 ↗
  • MalfunctionMar 4, 2026Material Separation

    USED 1 OR 2 TIMES AND BRISTLES STARTED FALLING OFF.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24506473 ↗
  • MalfunctionJan 22, 2026Break

    PROXABRUSHES STARTED BREAKING DURING USE AND NOT LASTING AS LONG AS THEY USUALLY DO BEFORE BREAKING HAPPENED WITH THE TWO PACKS SHE PURCHASED AT WALMART. (NO HARM WAS CAUSED AND WE HAVE SENT A REPLACEMENT AND RETURN ENVELOPE).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24150314 ↗
  • MalfunctionJan 14, 2026Break

    PROXABRUSH TIGHT KEEPS SNAPPING AT THE BASE OF THE WIRE. NO HARM WAS CAUSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24066989 ↗
  • MalfunctionJan 5, 2026Break

    CONSUMER STATES SHE HAS BEEN USING 872 FOR YEARS BUT THE QUALITY IS NOT THE SAME. SHE SAYS SHE CAN ONLY GET 1-2 USES OUT OF EACH ONE BEFORE THE TIP BREAKS OFF. NO INJURIES WERE REPORTED. SENDING RETURN ENVELOPE AND REPLACEMENT FROM DEPARTMENT STOCK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23970020 ↗
  • MalfunctionDec 23, 2025Break; Break

    CUSTOMER COMPLAINED PROXABRUSH/TIGHT GO BETWEEN CLEANERS, AT FIRST USE THE BRUSH BROKE OFF WHERE WIRE MET PLASTIC BASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23883771 ↗
  • MalfunctionNov 24, 2025Break; Break

    CUSTOMER COMPLAINED THE BRUSH AND METAL STEM PART OF THE PROXABRUSH KEEPS BREAKING OFF FROM THE RUBBER HANDLE. NO HARM WAS CAUSED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23639545 ↗
  • MalfunctionAug 15, 2025Break; Break

    CUSTOMER COMPLAINED THAT TIGHT GO BETWEEN CLEANER IS BREAKING OFF AT THE BASE. 3-4 HAVE BROKEN FROM A 10 PACK. THERE WAS NO INJURY REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22821419 ↗
  • MalfunctionAug 15, 2025Break; Break

    CONSUMER STATED THE TIP BROKE OFF THE HANDLE AFTER 4 USES AND WAS LODGED IN HER TEETH. SHE WAS ABLE TO REMOVE IT ON HER OWN. SHE SAID THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. SHE'S BEEN USING THEM FOR YEARS WITHOUT ISSUE BUT LATELY THEY ARE BREAKING WITH LITTLE USE. NO INJURY WAS REPORTED NOR DID SHE SEEK MEDICAL ATTENTION.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22821411 ↗
  • MalfunctionJul 29, 2025Break; Break

    CUSTOMER COMPLAINED A COUPLE OF TIMES THE BRUSH CAME OUT WITH THE WIRE IN THEIR TOOTH. THEY DID USE THE CORRECT SIZE FOR THEIR TEETH. ALSO, DID NOT FORCE THEM INTO THEIR TEETH.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22647232 ↗
  • MalfunctionJul 29, 2025Break; Break

    CUSTOMER COMPLAINED BRUSH GOT STUCK BETWEEN TEETH AND BROKE OFF. HER SON HAD TO USE PLIERS TO TAKE IT OUT. CUSTOMER SAID THIS HAPPENED ONCE BEFORE AND SHE WAS ABLE TO PULL OUT THE STUCK BRUSH WITH HER FINGERS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22646304 ↗
  • MalfunctionJul 23, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    CONSUMER STATED 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 22579227 ↗
  • MalfunctionJul 1, 2025Break; Break

    CUSTOMER PURCHASED GUM PROXABRUSH TIGHT AND HAD A BRUSH HEAD BREAK ONLY 4 DAYS INTO USE SO THEY HAD TO USE A NEW ONE WHICH BROKE 3 DAYS INTO USE. UPON GETTING FURTHER INFORMATION CUSTOMER MENTIONED TOOTHBRUSH BROKE AFTER ONLY 4 DAYS OF USE." " AFTER ONLY A COUPLE OF DAYS OF USE, THE WIRE BROKE THAT HELD THE BRUSH HEAD AND THE BRUSH HEAD GOT STUCK BETWEEN THEIR TEETH .

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22378515 ↗
  • MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    BRUSH HEAD OF THE PROXABRUSH FELL OFF DURING USE, AND THE BRUSH PART JUST DISLODGED AND GOT STUCK IN BETWEEN THE TEETH. SHE WAS ABLE TO USE A SECOND PROXABRUSH TO REMOVE THE BRUSH HEAD. THIS IS THE SECOND TIME A PROBLEM HAS OCCURED WITH THIS PACK, FIRST TIME THE PROXABRUSH BRUSH HEAD FELL OFF BEFORE USE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21704411 ↗
  • MalfunctionMar 26, 2025Break; Break

    CUSTOMER MENTIONED WIRE GOT STUCK IN BETWEEN TEETH DURING USE, WIRE BROKE OFF HANDLE AND WAS STUCK IN BETWEEN TEETH, THEY WERE ABLE TO REMOVE IT BUT WANTED TO INFORM US THAT IT HAPPENED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21704396 ↗
  • MalfunctionMar 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    CUSTOMER COMPLAINED AFTER USING IT ON A COUPLE OF TEETH THIS MORNING, THE HANDLE BROKE OFF AND THE BRUSH WAS STUCK BETWEEN HER TEETH, SHE FINALLY WAS ABLE TO GET IT OUT. SHE WAS SCARED THAT SHE WAS GOING TO HAVE TO GO TO THE DENTIST TO HAVE IT REMOVED. SHE HAS BEEN USING THEM FOR YEARS AND HAS NEVER HAD A PROBLEM. IT WAS THE LAST ONE OF THE PACKAGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21704387 ↗
  • MalfunctionNov 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    A HOME HEALTH CARE WORKER WHO CALLED FOR HER CLIENT. CLIENT USED GO BETWEEN CLEANER AND THE TIP BROKE OFF AND SHE SWALLOWED IT. SHE COULD BREATH, EAT, DRINK AND SWALLOW BUT CAN STILL FELT THE TIP IN HER THROAT. FOLLOW UP: CARE TAKER CALLED BACK TO SAY THAT CONSUMER HAD AN XRAY AND IT SHOWED THAT IT HAD PASSED. NOTHING ELSE TO BE DONE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20728913 ↗
  • MalfunctionOct 8, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

    CONSUMER SAID THE WIRE AT THE TIP OF THE BRUSH CAME APART.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20404272 ↗

Other TOOTHBRUSH, MANUAL devices

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Sources and updates

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