U By Kotex KOTEX TAMPONS (UDI 00036000515848)Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00036000515848), received between Sep 17, 2020 and Feb 26, 2026 — classified as 34 malfunctions.

The most frequently reported specific device problem is “Material Separation” (21 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 26, 2026Material Separation

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED VIA EMAIL THAT UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE RECEIVED MEDICAL ATTENTION TO REMOVE THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE DID NOT REPORT ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24455335 ↗
• MalfunctionJan 21, 2026Device Damaged Prior to Use

  CONSUMER REPORTED VIA EMAIL THAT PRIOR TO USE OF A TAMPON, SHE NOTICED THE PLUNGER PIECE OF THE APPLICATOR WAS BROKEN AND CUT OFF. SHE DECIDED TO USE THE TAMPON AND THEN UPON REMOVAL FROM HER BODY, SHE REPORTED THE STRING SEEMED SHORTENED. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS OR THE NEED FOR MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24130232 ↗
• MalfunctionNov 11, 2025Component Missing; Component Missing

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THAT SHE OPENED A TAMPON FOR USE AND NOTICED THERE WAS NO STRING. SHE DID NOT USE THE TAMPON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23523692 ↗
• MalfunctionOct 22, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART INTO PIECES. SHE MANUALLY REMOVED PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE WAS UNSURE IF SHE REMOVED ALL OF THE PIECES SO SHE HAD A VAGINAL EXAM FROM HER DOCTOR ON THE SAME DAY AND IT WAS CONFIRMED NO PLEDGET PIECES REMAINED INSIDE OF HER. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509629 ↗
• MalfunctionAug 20, 2024Break; Break

  CONSUMER REPORTED THAT AFTER INSERTION OF A TAMPON, SHE REMOVED THE APPLICATOR FROM HER VAGINAL CAVITY AND THE STRING BROKE. SHE NOTICED SOME OF THE STRING WAS ATTACHED TO THE PLEDGET AND SOME ATTACHED TO THE APPLICATOR. SHE ATTEMPTED TO MANUALLY REMOVE THE PLEDGET BUT ENDED UP RECEIVING ASSISTANCE FROM HER HUSBAND TO REMOVE IT 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 20007007 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  CONSUMER REPORTED VIA EMAIL THAT 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 19031167 ↗
• MalfunctionNov 14, 2023Break; Break

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING BROKE INTO PIECES. SHE MANUALLY REMOVED PIECES OF STRING FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18129551 ↗
• MalfunctionMar 22, 2023Material Separation; Material Separation

  REPORT 3 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED USING TAMPONS FROM TWO BOXES. FROM BOX 2, UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS FROM HER VAGINAL CAVITY, 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 16592069 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  REPORT 2 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED USING TAMPONS FROM TWO BOXES. FROM BOX 1, UPON REMOVAL OF ONE TAMPON FROM HER VAGINAL CAVITY, 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 16546021 ↗
• MalfunctionMar 15, 2023Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED USING TAMPONS FROM TWO BOXES. FROM BOX 1, UPON REMOVAL OF ONE TAMPON FROM HER VAGINAL CAVITY ON (B)(6) 2023, 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 16546003 ↗
• MalfunctionJan 23, 2023Component Missing; Component Missing

  CONSUMER REPORTED THAT PRIOR TO USE OF A TAMPON THE STRING WAS MISSING. SINCE SHE DID NOT USE THE TAMPON THERE WAS NO MEDICAL ATTENTION REQUIRED AND NO ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227333 ↗
• MalfunctionJan 23, 2023Component Missing; Component Missing

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON SHE DISCOVERED THE STRING WAS MISSING. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. THERE WERE NO REPORTS OF MEDICAL ATTENTION BEING REQUIRED OR ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16227315 ↗
• MalfunctionOct 6, 2022Material Separation; Material Separation

  CONSUMER REPORTED THAT WHEN ATTEMPTING TO REMOVE AN UNSPECIFIED NUMBER OF TAMPONS, SHE EXPRESSED THAT IT SEEMED LIKE THE STRINGS WERE WEAK. THEREFORE, SHE REMOVED THE PLEDGETS WITHOUT USING THE STRINGS, AND REPORTED THAT THE PLEDGETS FELL APART. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES FROM HER VAGINAL CAVITY. THE TAMPONS WERE WORN FOR APPROXIMATELY 8 HOURS AND WERE MOSTLY DRY UPON REMOVAL. NO MEDICAL ATTENTION WAS SOUGHT, AND NO ADVERSE HEALTH EFFECTS WERE EXPERIENCED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15549760 ↗
• MalfunctionOct 5, 2022Break; Break

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE STRING BROKE. SHE USED THE REMAINING ATTACHED PIECE OF STRING TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE SCHEDULED A MEDICAL VISIT FOR A MONTH OUT TO CONFIRM NO PIECES REMAINED. SHE DID NOT HAVE ANY SYMPTOMS AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL DETAILS ARE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546517 ↗
• MalfunctionOct 5, 2022Break; Material Separation; Break; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE STRING BROKE IN HALF. SHE ATTEMPTED TO USE THE REMAINING PART OF THE STRING TO REMOVE THE TAMPON BUT IT SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE SCHEDULED A MEDICAL VISIT FOR A MONTH OUT TO CONFIRM NO PIECES REMAINED. SHE DID NOT HAVE ANY SYMPTOMS AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL DETAILS ARE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546492 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE STRING SEPARATED LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. THE CONSUMER'S FRIEND WHO IS A NURSE ASSISTED WITH REMOVAL OF THE PLEDGET. SHE EXPERIENCED SOME PAIN WITH REMOVAL WHICH RESOLVED AFTER TAKING IBUPROFEN. NO SERIOUS ADVERSE HEALTH EFFECTS REPORTED. SINCE SHE PLANNED TO HAVE A FOLLOW-UP APPOINTMENT WITH MEDICAL, MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THIS FOLLOW-UP, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Pain

  MAUDE report 15520225 ↗
• MalfunctionJul 12, 2022Material Separation; Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. THE REMAINING PIECES WERE REMOVED AND SHE DID NOT REQUIRE MEDICAL ATTENTION. SHE DID NOT REPORT ANY EXPERIENCES OF AN ADVERSE HEALTH EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991266 ↗
• MalfunctionJul 12, 2022Material Separation; Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. THE REMAINING PIECES WERE REMOVED AND SHE DID NOT REQUIRE MEDICAL ATTENTION. SHE DID NOT REPORT ANY EXPERIENCES OF AN ADVERSE HEALTH EFFECT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14991025 ↗
• MalfunctionJun 28, 2022Difficult to Remove; Difficult to Remove

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED VIA EMAIL AND ON BEHALF OF HER DAUGHTER THAT AFTER INSERTION OF A TAMPON HER DAUGHTER REALIZED THE STRING WAS NOT ATTACHED TO THE PLEDGET. IT WAS INSTEAD INSIDE THE APPLICATOR. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE DAUGHTER'S USE OF THE PRODUCT AND OUTCOME, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 14840690 ↗
• MalfunctionJun 16, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING A PIECE OF PLEDGET INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14723667 ↗
• MalfunctionAug 18, 2021Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT MULTIPLE TAMPONS WERE PULLING APART VERY EASILY. 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 12339418 ↗
• MalfunctionJul 20, 2021Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED AN UNSPECIFIED AMOUNT OF TAMPONS WERE DIFFICULT TO REMOVE FROM HER VAGINAL CAVITY DUE TO THE STRING BEING TOO SHORT. SHE STATED THE STRING WAS HARD TO FIND HOWEVER SHE WAS ABLE TO FIND THE STRING AND REMOVED ALL THE TAMPONS USING THE STRING. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12199738 ↗
• MalfunctionJul 8, 2021Break; Break

  CONSUMER REPORTED UPON REMOVAL A TAMPON STRING BROKE INTO PIECES LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE ATTEMPTED TO REMOVE THE PLEDGET USING THE STRING BUT THEN THE REST OF THE STRING CAME OUT OF THE PLEDGET. SHE HAD TO MANUALLY REMOVE THE PLEDGET. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12134297 ↗
• MalfunctionJul 1, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET IN ONE PIECE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099949 ↗
• MalfunctionJul 1, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET IN ONE PIECE AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12099939 ↗