U By Kotex KOTEX TAMPONS (UDI 00036000534450)Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00036000534450), received between May 26, 2021 and Aug 26, 2026 — classified as 126 malfunctions.

The most frequently reported specific device problem is “Material Separation” (113 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 25 most recent of 126 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Component Missing

  Consumer reported upon attempted removal of a tampon, the string was missing. She received assistance from her husband to manually remove the pledged from her vaginal cavity. 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 50452723 ↗
• MalfunctionApr 6, 2026Material Separation

  CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT UPON ATTEMPTED REMOVAL OF A TAMPON, IT FELL APART INSIDE OF HER. THE MOTHER REPORTED SHE ASSISTED WITH REMOVING THE REMAINING PLEDGET FROM HER DAUGHTER'S VAGINAL CAVITY AND NO MEDICAL CARE WAS REQUIRED. SHE DID NOT REPORT ANY SERIOUS ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793035 ↗
• MalfunctionMar 24, 2026Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING SEPARATED. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE REPORTED SOME CRAMPING WHICH RESOLVED WHEN THE PLEDGET WAS REMOVED. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 24679883 ↗
• MalfunctionMar 24, 2026Component Missing

  CONSUMER REPORTED UPON OPENING AN UNSPECIFIED NUMBER OF TAMPONS FOR USE, THE STRING WAS MISSING. SHE DID NOT USE THE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673364 ↗
• MalfunctionMar 24, 2026Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING SEPARATED. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE REPORTED SOME CRAMPING WHICH RESOLVED WHEN THE PLEDGET WAS REMOVED. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 24673342 ↗
• MalfunctionMar 24, 2026Component Missing

  CONSUMER REPORTED UPON OPENING AN UNSPECIFIED NUMBER OF TAMPONS FOR USE, THE STRING WAS MISSING. SHE DID NOT USE THE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24673338 ↗
• MalfunctionNov 11, 2025Material Separation; Material Separation

  CONSUMER REPORTED SHE LAST WORE A TAMPON ON (B)(6) 2025 AND THE NEXT DAY AFTER USING THE REST ROOM, A PIECE OF TAMPON CAME OUT OF HER BODY. 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 23523827 ↗
• MalfunctionSep 11, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED IN ONE PIECE FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. 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 23027085 ↗
• MalfunctionSep 19, 2024Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED THAT PRIOR TO USE OF A TAMPON, SHE NOTICED THE TIP OF THE APPLICATOR WAS SPREAD OPEN. SHE PROCEEDED TO CHECK ADDITIONAL TAMPONS FROM THE SAME CARTON AND ALLEGED THERE WERE APPROXIMATELY 7-11 TAMPONS AFFECTED. SHE DID NOT USE THE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20256935 ↗
• MalfunctionAug 21, 2024Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED THAT AFTER INSERTION OF A TAMPON, THE STRING WAS NOTICED TO BE SHORT. SHE WAS ABLE TO REMOVE THE TAMPON FROM HER VAGINAL CAVITY. IT IS UNKNOWN IF SHE WAS ABLE TO USE THE STRING FOR REMOVAL. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20019676 ↗
• MalfunctionJun 24, 2024Material Separation; Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE FROM HER VAGINAL CAVITY. 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 19594421 ↗
• MalfunctionJun 24, 2024Material Separation; Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE FROM HER VAGINAL CAVITY. 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 19594411 ↗
• MalfunctionMar 11, 2024Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18873658 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. 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 18498455 ↗
• MalfunctionJan 11, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18498177 ↗
• MalfunctionOct 19, 2023Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING SEPARATED FROM THE PLEDGET. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 17964899 ↗
• MalfunctionAug 23, 2023Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT UPON INSERTION OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET AND LEFT THE PLEDGET INSIDE HER VAGINAL CAVITY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 17602568 ↗
• MalfunctionAug 9, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. 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 17492107 ↗
• MalfunctionJul 27, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY WHICH SHE REPORTED HURT AT THE TIME BUT IT HAS RESOLVED. SHE DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Pain

  MAUDE report 17404614 ↗
• MalfunctionJul 7, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART INTO TWO PIECES. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17277094 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  REPORT 2 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. 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 17262365 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  REPORT 1 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. 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 17261918 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  REPORT 3 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. 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 17261492 ↗
• MalfunctionJul 5, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. 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 17260409 ↗
• MalfunctionJun 14, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON INSERTION AND REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPON APPLICATORS, SHE NOTICED PLEDGET PIECES ON THE APPLICATOR. AFTER REMOVAL OF THE UNSPECIFIED NUMBER OF TAMPONS FROM HER VAGINAL CAVITY AND AFTER WIPING WITH TOILET PAPER, SHE NOTICED PLEDGET PIECES ON THE TOILET PAPER. SHE REPORTED FEELING CONFIDENT THAT NO PIECES OF PLEDGET REMAINED IN HER VAGINAL CAVITY. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CHECK ON THE CONSUMER'S CURRENT STATUS; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17129674 ↗