CVS Health SMPRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00050428348925), received between Mar 13, 2020 and Sep 16, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

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.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2020Material Separation

  CONSUMER STATED "JUST BOUGHT TODAY AND SHE USED THEM, AND THE VERY SHARP GREEN BRISTLES FELL OUT. VERY SHARP AND ONE STUCK IN HER GUMS." SHE WAS ABLE TO PULL IT OUT. NO INJURY BUT FEELS IT COULD HAVE BEEN VERY DANGEROUS TO A CHILD. PRODUCT NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10540592 ↗
• MalfunctionMar 13, 2020Detachment of Device or Device Component

  CONSUMER STATED THE BLUE BRISTLES FELL OUT OF THE BRUSH HEAD. SHE USED IT FOR 1 1/2 WEEKS. THIS IS THE FIRST TIME SHE HAS PURCHASED THIS PRODUCT. CONSUMER RETURNED THE PRODUCT TO THE STORE. EMAILED CVS AND REQUESTED PRODUCT BUT WAS UNABLE TO RETRIEVE THE PRODUCT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9832414 ↗