U By Kotex KOTEX TAMPONS (UDI 00036000515824)Recalls & reported problems

Summary

The FDA's MAUDE database contains 50 adverse event reports that list this exact device (DI 00036000515824), received between May 26, 2021 and Mar 9, 2026 — classified as 50 malfunctions.

The most frequently reported specific device problem is “Material Separation” (37 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 50 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 9, 2026Component Missing

  CONSUMER REPORTED VIA EMAIL THAT SHE ATTEMPTED TO USE A TAMPON AND THERE WAS NO STRING ATTACHED TO THE TAMPON. 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: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24548241 ↗
• MalfunctionJul 17, 2025Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF A TAMPON, THE STRING SEPARATED IN ONE PIECE. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY WHILE WEARING GLOVES. CONSUMER REPORTED THE TAMPON HAD BEEN IN USE FOR A TOTAL OF 1 HOUR. SHE EXPERIENCED VAGINAL PAIN FROM HER GLOVED FINGERS FOLLOWING MANUAL REMOVAL OF THE PLEDGET. NO TREATMENT WAS REQUIRED. SHE STATED THAT AFTER THIS EVENT, SHE CHECKED OTHER TAMPONS IN THE PACKAGE AND OBSERVED THE STRING DETACHED IN VARYING WAYS, SEPARATING IN ONE PIECE IN SOME INSTANCES AND SEPARATING INTO MULTIPLE PIECES IN OTHERS. THESE TAMPONS WERE NOT USED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Pain

  MAUDE report 22529657 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, A PIECE OF THE APPLICATOR AND A PIECE OF THE PLEDGET REMAINED INSIDE OF HER. SHE MANUALLY REMOVED THE 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 18987146 ↗
• MalfunctionMar 27, 2024Material Separation; Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, A PIECE OF THE APPLICATOR AND A PIECE OF THE PLEDGET REMAINED INSIDE OF HER. SHE MANUALLY REMOVED THE 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 18987112 ↗
• MalfunctionJun 8, 2023Component Missing; Component Missing

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON FROM HER VAGINAL CAVITY, SHE DISCOVERED THE STRING WAS MISSING. SINCE SHE WAS UNABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY, SHE RECEIVED ASSISTANCE FROM HER HUSBAND TO MANUALLY REMOVE IT. SHE EXPERIENCED PAIN DURING REMOVAL AND CRAMPING AFTER REMOVAL AND THESE SYMPTOMS RESOLVED. SHE ALSO EXPERIENCED VAGINAL SORENESS AND TENDERNESS AFTER REMOVAL WHICH HAS IMPROVED. SHE REPORTED USING OTC TYLENOL AND MOTRIN AND AN UNSPECIFIED PRESCRIPTION PAIN PILL PREVIOUSLY PRESCRIBED FOR AN UNRELATED EVENT. SHE DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Cramp(s) /Muscle Spasm(s); Discomfort; Pain

  MAUDE report 17089637 ↗
• MalfunctionMay 2, 2023Material Separation; Material Separation

  REPORT 5 OF 5. CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT PRIOR TO INSERTING A TAMPON INTO HER VAGINAL CAVITY, THE STRING SEPARATED FROM THE TAMPON PLEDGET. SHE DISCARDED THE TAMPON SINCE IT WAS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852558 ↗
• MalfunctionMay 2, 2023Material Separation; Material Separation

  REPORT 4 OF 5. CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT PRIOR TO INSERTING A TAMPON INTO HER VAGINAL CAVITY, THE STRING SEPARATED FROM THE TAMPON PLEDGET. SHE DISCARDED THE TAMPON SINCE IT WAS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852554 ↗
• MalfunctionMay 2, 2023Material Separation; Material Separation

  REPORT 3 OF 5. CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT PRIOR TO INSERTING A TAMPON INTO HER VAGINAL CAVITY, THE STRING SEPARATED FROM THE TAMPON PLEDGET. SHE DISCARDED THE TAMPON SINCE IT WAS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852552 ↗
• MalfunctionMay 2, 2023Material Separation; Material Separation

  REPORT 2 OF 5. CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT PRIOR TO INSERTING A TAMPON INTO HER VAGINAL CAVITY, THE STRING SEPARATED FROM THE TAMPON PLEDGET. SHE DISCARDED THE TAMPON SINCE IT WAS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852547 ↗
• MalfunctionMay 2, 2023Material Separation; Material Separation

  REPORT 1 OF 5. CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT PRIOR TO INSERTING A TAMPON INTO HER VAGINAL CAVITY, THE STRING SEPARATED FROM THE TAMPON PLEDGET. SHE DISCARDED THE TAMPON SINCE IT WAS NOT USABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16852516 ↗
• MalfunctionApr 20, 2023Material Separation; Material Separation

  CONSUMER REPORTED AFTER INSERTION OF A TAMPON PLEDGET AND REMOVAL OF THE APPLICATOR FROM HER VAGINAL CAVITY, THE STRING DETACHED FROM THE PLEDGET. 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 16778804 ↗
• MalfunctionFeb 20, 2023Difficult to Remove; Difficult to Remove

  REPORT 4 OF 4. CONSUMER REPORTED PRIOR TO USE A TAMPON STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPON AND SHE DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405968 ↗
• MalfunctionFeb 20, 2023Difficult to Remove; Difficult to Remove

  REPORT 3 OF 4. CONSUMER REPORTED PRIOR TO USE A TAMPON STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPON AND SHE DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405960 ↗
• MalfunctionFeb 20, 2023Difficult to Remove; Difficult to Remove

  REPORT 2 OF 4. CONSUMER REPORTED PRIOR TO USE A TAMPON STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPON AND SHE DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405958 ↗
• MalfunctionFeb 20, 2023Difficult to Remove; Difficult to Remove

  REPORT 1 OF 4. CONSUMER REPORTED PRIOR TO USE A TAMPON STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPON AND SHE DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16405955 ↗
• MalfunctionFeb 2, 2023Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED SHE OPENED A TAMPON FOR USE AND THE STRING APPEARED SHORT. SHE DID NOT USE THE TAMPON AND DISCARDED IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16282940 ↗
• MalfunctionDec 19, 2022Material Separation; Material Separation

  CONSUMER REPORTED THAT SHE REMOVED A TAMPON PLEDGET FROM HER VAGINAL CAVITY AND EXPERIENCED SOME PAIN. DURING AN UNSPECIFIED PERIOD OF TIME LATER, SHE EXPERIENCED A FEVER, COUGH AND VAGINAL ODOR. SHE WENT TO THE EMERGENCY ROOM WHERE THEY DID A VAGINAL EXAM AND REMOVED ADDITIONAL PLEDGET PIECES FROM HER VAGINAL CAVITY. SHE WAS DIAGNOSED WITH A YEAST INFECTION AND BACTERIAL VAGINOSIS. SHE WAS PRESCRIBED ORAL CEFADROXIL AND FLUCONAZOLE AND HER SYMPTOMS HAVE RESOLVED. THE CONSUMER DECLINED TO ALLOW ANY ADDITIONAL CONTACTS WITH HER; THEREFORE, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Cough; Fever; Foreign Body In Patient; Pain

  MAUDE report 16009070 ↗
• MalfunctionSep 13, 2022Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED REMOVAL OF ONE OF HER TAMPONS WAS A CHALLENGE WHICH SHE LATER REALIZED WAS DUE TO THE STRING BEING SHORTER THAN NORMAL. SHE CONFIRMED SHE WAS ABLE TO REMOVE THE TAMPON HERSELF. SHE DID NOT REPORT THE NEED FOR MEDICAL ATTENTION OR HAVING ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411441 ↗
• MalfunctionAug 25, 2022Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL A TAMPON FELL APART LEAVING PIECES OF 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 15294560 ↗
• MalfunctionAug 2, 2022Difficult to Insert; Difficult to Insert

  REPORT 2 OF 4. CONSUMER REPORTED DURING ATTEMPTED EXPULSION OF A TAMPON PLEDGET THE APPLICATOR PLUNGER SEPARATED FROM THE APPLICATOR BARREL LEAVING THE BARREL INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE BARREL, ALONG WITH 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 15153099 ↗
• MalfunctionAug 2, 2022Difficult to Insert; Difficult to Insert

  REPORT 3 OF 4. CONSUMER REPORTED DURING ATTEMPTED EXPULSION OF A TAMPON PLEDGET THE APPLICATOR PLUNGER SEPARATED FROM THE APPLICATOR BARREL LEAVING THE BARREL INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE BARREL, ALONG WITH 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 15153046 ↗
• MalfunctionAug 2, 2022Difficult to Insert; Difficult to Insert

  REPORT 4 OF 4. CONSUMER REPORTED DURING ATTEMPTED EXPULSION OF A TAMPON PLEDGET THE APPLICATOR PLUNGER SEPARATED FROM THE APPLICATOR BARREL LEAVING THE BARREL INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE BARREL, ALONG WITH 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 15153028 ↗
• MalfunctionAug 2, 2022Difficult to Insert; Difficult to Insert

  REPORT 1 OF 4. CONSUMER REPORTED DURING ATTEMPTED EXPULSION OF A TAMPON PLEDGET THE APPLICATOR PLUNGER SEPARATED FROM THE APPLICATOR BARREL LEAVING THE BARREL INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE BARREL, ALONG WITH 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 15153026 ↗
• MalfunctionJun 3, 2022Material Separation; Material Separation

  CONSUMER REPORTED VIA EMAIL THE STRING WAS TOO SHORT ON AN UNSPECIFIED NUMBER OF TAMPONS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION AND CLARIFICATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 14593562 ↗
• MalfunctionApr 6, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL OF A TAMPON IT FELL APART 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 14026713 ↗