GUMRecalls & reported problems across all models
Sunstar Americas, Inc. · 16 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls
- 0
We found 16 models of GUM by Sunstar Americas, Inc. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Jun 5, 2023 and Sep 22, 2026 — classified as 3 injuries, 51 malfunctions.
The most frequently reported specific device problem is “Break” (26 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported GUM problems
Device problems
- Break26
- Detachment of Device or Device Component19
- Material Separation5
- Insufficient Device Problem Information1
- Loss of or Failure to Bond1
- Separation Problem1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions51
- Hypersensitivity/Allergic reaction1
- Inflammation1
- Pain1
- Tooth Fracture1
GUM models
16 models, most reported first. Each model has its own page with its reports, recalls and device details.
- GUM® 872TOOTHBRUSH, MANUAL19 reports
- GUM® 872TOOTHBRUSH, MANUAL8 reports
- GUM® 871TOOTHBRUSH, MANUAL4 reports
- GUM® 3614TOOTHBRUSH, MANUAL4 reports
- GUM® 3612TOOTHBRUSH, MANUAL3 reports
- GUM® 872TOOTHBRUSH, MANUAL3 reports
- GUM® 1614TOOTHBRUSH, MANUAL2 reports
- GUM® 3612TOOTHBRUSH, MANUAL2 reports
- GUM® 3614TOOTHBRUSH, MANUAL2 reports
- GUM® 872TOOTHBRUSH, MANUAL1 report
- GUM® 871TOOTHBRUSH, MANUAL1 report
- GUM® 3614TOOTHBRUSH, MANUAL1 report
- GUM® 874TOOTHBRUSH, MANUAL1 report
- GUM® 124TOOTHBRUSH, MANUAL1 report
- GUM® 614TOOTHBRUSH, MANUAL1 report
- GUM® 414TOOTHBRUSH, MANUAL1 report
Recent GUM adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 22, 2026Break
CONSUMER WAS WEDGING THE BRUSH IN BETWEEN HER TEETH IN THE BOTTOM QUADRANT IN THE FRONT AND IT BROKE OFF THE BRUSH WAS STUCK IN BETWEEN HER TEETH. IT WAS STUCK BETWEEN 22 AND 23. CONSUMER PUSHED THE BROKEN BRUSH OUT WITH HER FINGERS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50856473 ↗MalfunctionAug 25, 2026Material Separation
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50441331 ↗MalfunctionAug 4, 2026Break
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50134307 ↗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 ↗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 ↗MalfunctionFeb 24, 2026Break
SHE HAS BEEN USING THE 872'S AND THEY ARE BREAKING FROM THE HANDLE AFTER A FEW USES. SHE DOES NOT HAVE THE BROKEN ONES TO SEND BACK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434376 ↗InjuryFeb 3, 2026Use of Device Problem
DENTAL DAMAGE CAUSED BY PRODUCT HELLO, I AM CONTACTING YOU REGARDING MY PURCHASE OF GUM PROXABRUSH GO-BETWEENS ¿ ULTRA TIGHT (ORDER ID: (B)(4). DESPITE BEING ADVERTISED AS SOFT AND SAFE FOR GUM HEALTH, THESE INTERDENTAL BRUSHES WERE EXTREMELY HARD AND RIGID WHEN USED. DURING NORMAL USE, THE EXCESSIVE HARDNESS CAUSED DAMAGE TO MY TOOTH, RESULTING IN A CHIPPED TOOTH TIP. THIS IS COMPLETELY UNACCEPTABLE FOR A DENTAL CARE PRODUCT. ADDITIONALLY, THE BRUSHES SHOWED POOR CONSTRUCTION AND INSTABILITY, MAKING THEM UNSAFE FOR ORAL USE. A PRODUCT INTENDED FOR ULTRA-TIGHT SPACES SHOULD BE GENTLE AND CONTROLLED, NOT STRONG ENOUGH TO CAUSE PHYSICAL DENTAL DAMAGE. THIS PRODUCT IS CLEARLY NOT AS DESCRIBED AND REPRESENTS A SERIOUS SAFETY ISSUE.
Patient problems: Tooth Fracture
MAUDE report 24252418 ↗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 15, 2026Material Separation
USED ONE BRUSH, ONE TIME AND ALL BRISTLES FALLING OUT. BLUE HANDLE ¿ PROXABRUSH - 1614 PURCHASED: MAPLE GARDEN ((B)(6)). CUST CONFIRMED BRUSH AVAILABLE FOR RETURN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24081523 ↗MalfunctionJan 14, 2026Break
I HAVE USED YOUR PROXABRUSHES FOR A FEW YEARS NOW BUT HAVE A PROBLEM WITH THE CONTAINER I AM USING AS TWO OF THE BRUSHES FELL OFF THE STEMS WHEN I WAS FIRST USING THEM. NEVER HAPPENED BEFORE. THE WIRE BROKE AND THE HEAD CAME OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24067069 ↗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 ↗
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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