Toothbrush, Manual
FDA adverse event reports and recall history for toothbrush, manual (product code EFW), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 1,542
- Deaths
- 1
- Injuries
- 250
- Malfunctions
- 1,216
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2026-01-27Open, ClassifiedStorage
Toothbrushes, labeled as: ORAL B TOOTH BRUSH SHINY CLEAN SOFT 12CT; COLGATE TOOTH BRUSH MED. 12CT; ADULT TOOTHPASTE W BRUSH (WHITENING) 6.4oz/24ct; ADULT TOOTHPASTE W BRUSH (ANTICAV) 6.4oz/24ct.
Potential exposure of rodents and rodent activity in the distribution center.
- 2022-08-17Open, ClassifiedStorage
TRVL KIT TOTHBRSH CAP PASTE IN POUCH 1CT, SKU 900737
Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.
- 2020-01-30Open, ClassifiedUse error
fridababy SmileFrida the TOOTHHUGGER 18+ months Triple Angle Brush Cleans All Sides at Once
FridaBaby has been made aware through customer reports that the product is being used outside of the labeled directions. Specifically, repeated chewing or biting on the SmileFrida, the ToothHugger has caused deterioration in the outer layer of the brush and in very rare occasions, may cause the hard plastic brush head to break, exposing a small metal piece welded inside the brush head.
- 2015-02-26TerminatedUnder Investigation by firm
Manual Toothbrush; SilverCare Junior 2/6 years Antibacterial Toothbrush Made in Italy The product is intended for over the counter use as a toothbrush. The silver plating is an antimicrobial agent which maintains the cleanliness of the brush by preventing growth of bacteria on and between the filaments after use.
The toothbrush head can potentially disengage from the handle.
- 2005-08-03TerminatedOther
Orajel toddler EXTRA GENTLE Yellow Manual Toothbrush, Model 7531. Made in China --- The toothbrush is to be replaced every 3 months. --- Firm on label: DEL PHARMACEUTICALS, INC. a subsidiary of Del Laboratories, Inc. Uniondale, NY 11553
Firm received several consumer complaints that the elastomer head of the toothbrush had separated (broke) from the handle during use and could pose a choking hazard to children.
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