U By Kotex KOTEX TAMPONS (UDI 00036000535198)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00036000535198), received between Mar 14, 2023 and Sep 16, 2025 — classified as 6 malfunctions.

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

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 16, 2025Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED VIA EMAIL THAT SHE FOUND AN UNSPECIFIED NUMBER OF TAMPONS THAT HAD PETALS FOLDED OUT, MAKING THEM IMPOSSIBLE TO USE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S POTENTIAL USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23065038 ↗
• MalfunctionApr 1, 2025Material Separation; Material Separation

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT UPON REMOVAL OF A SUPER PLUS ABSORBENCY TAMPON, THE STRING SEPARATED FROM THE PLEDGET. AS HER DAUGHTER MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY, THE PLEDGET FELL APART INTO PIECES. HER DAUGHTER MANUALLY REMOVED ALL OF THE REMAINING PLEDGET PIECES. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21745908 ↗
• MalfunctionDec 6, 2024Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, A PIECE OF PLASTIC PLEDGET WRAP CAME OUT WITH IT. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862917 ↗
• MalfunctionMar 14, 2023Break; Break

  REPORT 3 OF 3. CONSUMER REPORTED THAT PRIOR TO INSERTION OF A TAMPON, SHE TESTED THE STRING BY PULLING ON IT AND THE STRING BROKE INTO PIECES. SHE DID NOT USE THE TAMPON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536587 ↗
• MalfunctionMar 14, 2023Break; Break

  REPORT 2 OF 3. CONSUMER REPORTED THAT PRIOR TO INSERTION OF A TAMPON, SHE TESTED THE STRING BY PULLING ON IT AND THE STRING BROKE INTO PIECES. SHE DID NOT USE THE TAMPON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536576 ↗
• MalfunctionMar 14, 2023Break; Break

  REPORT 1 OF 3. CONSUMER REPORTED THAT PRIOR TO INSERTION OF A TAMPON, SHE TESTED THE STRING BY PULLING ON IT AND THE STRING BROKE INTO PIECES. SHE DID NOT USE THE TAMPON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16536569 ↗