U By Kotex KOTEX TAMPONS (UDI 00036000515831)Recalls & reported problems

Summary

The FDA's MAUDE database contains 178 adverse event reports that list this exact device (DI 00036000515831), received between Oct 9, 2020 and Sep 23, 2026 — classified as 178 malfunctions.

The most frequently reported specific device problem is “Material Separation” (154 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 178 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Material Separation

  Consumer reported on behalf of her daughter that with an unspecified number of tampons, the string separated from the pledget during removal. In all but one case, she was able to manually remove the pledget from her vaginal cavity. With the other case, she went to the emergency room for removal. She did not experience any serious adverse events.

  Patient problems: Foreign Body In Patient

  MAUDE report 50869629 ↗
• MalfunctionAug 6, 2026Difficult to Remove

  Patient problems: Foreign Body In Patient

  MAUDE report 50164888 ↗
• MalfunctionJun 15, 2026Difficult to Remove

  CONSUMER REPORTED VIA EMAIL THAT UPON REMOVAL OF A TAMPON, SHE REALIZED THE STRING WAS SHORT AND SHE HAD TO SEARCH FOR IT TO REMOVE THE PLEDGET. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS AND DID NOT REQUIRE MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25504236 ↗
• MalfunctionFeb 19, 2026Material Separation

  CONSUMER REPORTED VIA EMAIL THAT UPON REMOVAL OF A TAMPON, THE STRING CAME OFF. SHE MANUALLY REMOVED THE PLEDGET FROM 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 24390615 ↗
• MalfunctionOct 22, 2025Product Quality Problem; Product Quality Problem

  REPORT 2 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED VIA EMAIL THAT PRIOR TO USE OF A REGULAR ABSORBENCY TAMPON, THE INSERTION TUBE WAS OPEN AT THE TOP WHICH HURT IF SHE USED IT. SHE DID NOT REPORT ANY SERIOUS ADVERSE HEALTH EFFECTS OR THE NEED FOR MEDICAL ATTENTION.

  Patient problems: Pain

  MAUDE report 23356742 ↗
• MalfunctionOct 22, 2025Product Quality Problem; Product Quality Problem

  REPORT 1 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED VIA EMAIL THAT PRIOR TO USE OF AN UNSPECIFIED NUMBER OF REGULAR ABSORBENCY TAMPONS, THE INSERTION TUBE WAS OPEN AT THE TOP WHICH HURT IF SHE USED IT. SHE DID NOT REPORT ANY SERIOUS ADVERSE HEALTH EFFECTS OR THE NEED FOR MEDICAL ATTENTION.

  Patient problems: Pain

  MAUDE report 23356487 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  REPORT 2 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A REGULAR ABSORBENCY TAMPON, THE PLEDGET UNRAVELED AND BROKE INTO PIECES. SHE MANUALLY REMOVED ANY REMAINING PIECES FROM HER VAGINAL CAVITY. CONSUMER REPORTED SHE CALLED TELEHEALTH AND WAS ADVISED IF SHE HAD SYMPTOMS TO SEEK MEDICAL. SHE DID NOT REQUIRE MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22804042 ↗
• MalfunctionAug 14, 2025Material Separation; Material Separation

  REPORT 1 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A REGULAR ABSORBENCY TAMPON, THE PLEDGET UNRAVELED AND BROKE INTO PIECES. SHE MANUALLY REMOVED ANY REMAINING PIECES FROM HER VAGINAL CAVITY. CONSUMER REPORTED SHE CALLED TELEHEALTH AND WAS ADVISED IF SHE HAD SYMPTOMS TO SEEK MEDICAL. SHE DID NOT REQUIRE MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22803977 ↗
• MalfunctionJun 20, 2025Material Separation; Material Separation

  CONSUMER REPORTED VIA EMAIL THAT SHE IS A USER OF REGULAR ABSORBENCY TAMPONS AND AFTER USE OF A DOUCHE, A PIECE OF TAMPON PLEDGET CAME OUT OF 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 22297738 ↗
• MalfunctionFeb 5, 2025Material Separation; Material Separation

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET WAS SOMEWHAT DRY AND IT FELL APART INTO TWO PIECES WITH ONE PIECE REMAINING INSIDE OF HER. SHE WAS UNABLE TO MANUALLY REMOVE THE REMAINING PLEDGET PIECE FROM HER VAGINAL CAVITY SO SHE WENT TO THE EMERGENCY ROOM WHERE IT WAS FULLY REMOVED. SHE DID NOT HAVE ANY FOLLOW-UP MEDICAL REQUIRED AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 21313349 ↗
• MalfunctionJul 23, 2024Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, 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 19805811 ↗
• MalfunctionJun 19, 2024Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED PLEDGET PIECES FROM HER VAGINAL CAVITY AND ALLEGED TO STILL HAVE PIECES INSIDE OF HER. SHE HAD NOT SOUGHT MEDICAL AND SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO FOLLOW-UP REGARDING THE CONSUMER'S OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19567007 ↗
• MalfunctionMay 8, 2024Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED THAT UPON REMOVAL OF A TAMPON ON (B)(6)2024, THE PLEDGET FELL APART INTO PIECES. SINCE SHE WAS UNABLE TO REMOVE THE PIECES HERSELF, SHE RECEIVED MEDICAL ATTENTION ON (B)(6) 2024 AND THE PIECES WERE REMOVED FROM HER VAGINAL CAVITY BY THE DOCTOR. SHE REPORTED HAVING CRAMPING AFTER REMOVAL. SHE DOES NOT HAVE ANY MEDICAL FOLLOW-UPS PLANNED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Foreign Body In Patient

  MAUDE report 19268713 ↗
• MalfunctionApr 26, 2024Material Separation; Material Separation

  REPORT 3 OF 3. CONSUMER REPORTED THAT WHEN SHE PULLED ON THE STRING OF A TAMPON FOR REMOVAL, THE PLEDGET FELL APART. SHE WAS ABLE TO GET THE PLEDGET OUT COMPLETELY AND NO PIECES REMAINED INSIDE OF HER. 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 19192492 ↗
• MalfunctionApr 26, 2024Material Separation; Material Separation

  REPORT 2 OF 3. CONSUMER REPORTED THAT WHEN SHE PULLED ON THE STRING OF A TAMPON FOR REMOVAL, THE PLEDGET FELL APART. SHE WAS ABLE TO GET THE PLEDGET OUT COMPLETELY AND NO PIECES REMAINED INSIDE OF HER. 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 19192491 ↗
• MalfunctionApr 26, 2024Material Separation; Material Separation

  REPORT 1 OF 3. CONSUMER REPORTED THAT WHEN SHE PULLED ON THE STRING OF A TAMPON FOR REMOVAL, THE PLEDGET FELL APART. SHE WAS ABLE TO GET THE PLEDGET OUT COMPLETELY AND NO PIECES REMAINED INSIDE OF HER. 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 19192420 ↗
• MalfunctionApr 26, 2024Material 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 REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19192397 ↗
• MalfunctionJan 5, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE REPORTED THAT SOME PIECES OF PLEDGET EXPELLED FROM HER BODY FOR A COUPLE OF DAYS AND SHE MANUALLY REMOVED ANY REMAINING 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 18452335 ↗
• MalfunctionOct 4, 2023Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT WHILE USING THE STRING FOR REMOVAL OF THE TAMPON, THE PLEDGET FELL APART AND LEFT PIECES INSIDE OF 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 17868277 ↗
• MalfunctionOct 3, 2023Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED VIA E-MAIL THAT UPON USE OF A TAMPON, THE PLEDGET FELL APART INTO PIECES. SHE NOTICED PIECES HAD BEEN LEFT BEHIND WHEN THEY EXPELLED FROM HER VAGINAL CAVITY WHILE USING THE RESTROOM. 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 17863115 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  REPORT 3 OF 3. 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 17739343 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  REPORT 2 OF 3. 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 17739330 ↗
• MalfunctionSep 13, 2023Material Separation; Material Separation

  REPORT 1 OF 3. 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 17739324 ↗
• MalfunctionSep 11, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING SEPARATED FROM THE PLEDGET. SHE WAS ABLE TO REMOVE 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 17721307 ↗
• MalfunctionSep 11, 2023Break; Break

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING BROKE. SHE WAS ABLE TO REMOVE 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 17721282 ↗