U By Kotex KOTEX TAMPONS (UDI 00036000515817)Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00036000515817), received between Sep 17, 2020 and Oct 15, 2025 — classified as 46 malfunctions.

The most frequently reported specific device problem is “Material Separation” (27 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 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 15, 2025Component Missing; Component Missing

  CONSUMER REPORTED VIA EMAIL THAT UPON OPENING AN UNSPECIFIED NUMBER OF SUPER ABSORBENCY TAMPONS, THE STRING WAS MISSING PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290510 ↗
• MalfunctionOct 15, 2025Component Missing; Component Missing

  CONSUMER REPORTED VIA EMAIL THAT UPON OPENING AN UNSPECIFIED NUMBER OF SUPER ABSORBENCY TAMPONS, THE STRING WAS MISSING PRIOR TO USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23290022 ↗
• MalfunctionSep 19, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE SOUGHT MEDICAL ASSISTANCE FOR REMOVAL OF THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 23098145 ↗
• MalfunctionJun 20, 2025Difficult to Remove; Difficult to Remove

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A SUPER ABSORBENCY TAMPON; SHE WAS NOT ABLE TO LOCATE A STRING SO SHE ASSUMED SHE HADN'T PUT ONE IN AND PROCEEDED TO INSERT ANOTHER TAMPON. WHILE AT WORK SHE EXPERIENCED MINOR VAGINAL PAIN AND THEN REALIZED SHE NOW HAD TWO PLEDGETS INSIDE OF HER. SHE WAS ABLE TO MANUALLY REMOVE THE SECOND PLEDGET HERSELF. SHE HAD HER ROOMMATE ASSIST WITH REMOVAL OF THE FIRST PLEDGET AND THEN DETERMINED THE FIRST PLEDGET HAD A SHORT STRONG. HER PAIN HAS RESOLVED. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 22296803 ↗
• MalfunctionOct 18, 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 DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20485914 ↗
• MalfunctionJun 11, 2024Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED THAT WHEN PREPARING A TAMPON FOR USE, THE STRING SEPARATED FROM THE PLEDGET. SHE CHECKED TAMPONS FROM TEN BOXES, ALL WITH THE SAME LOT CODE, AND ALLEGED THE STRING SEPARATED FROM ALL OF THEM. NONE OF THE TAMPONS WERE USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509252 ↗
• MalfunctionApr 5, 2024Material Separation; Material Separation

  CONSUMER REPORTED PRIOR TO INSERTION OF A TAMPON THAT THE STRING WAS PRESENT. UPON ATTEMPTED REMOVAL OF THE TAMPON, SHE ALLEGED THAT THE STRING WAS MISSING. SHE REPORTED THAT SHE AND HER HUSBAND WERE UNSUCCESSFUL IN ATTEMPTING TO REMOVE THE TAMPON. SHE WENT TO THE EMERGENCY ROOM TO HAVE THE TAMPON REMOVED FROM HER VAGINAL CAVITY. IT WAS REPORTED THAT THE DOCTOR CONFIRMED THE STRING WAS MISSING AT THAT TIME. THE CONSUMER WAS PRESCRIBED AN UNKNOWN ORAL ANTIBIOTIC AS A PRECAUTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19052289 ↗
• MalfunctionMar 1, 2024Material Separation; Material Separation

  REPORT 2 OF 2. 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 18816728 ↗
• MalfunctionMar 1, 2024Material Separation; Material Separation

  REPORT 1 OF 2. 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 18816715 ↗
• MalfunctionMay 4, 2023Material Separation; Material Separation

  REPORT 2 OF 2. 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 DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867325 ↗
• MalfunctionMay 4, 2023Material Separation; Material Separation

  REPORT 1 OF 2. 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 DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16867317 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE PLEDGET FELL APART INTO PIECES. 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 15920550 ↗
• MalfunctionDec 5, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE PLEDGET FELL APART INTO PIECES. 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 15920432 ↗
• MalfunctionSep 30, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS THE STRING SEPARATED FROM THE PLEDGET. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE EXPERIENCED SOME DISCOMFORT UPON REMOVAL WHICH WENT AWAY AS SOON AS THE PLEDGET WAS REMOVED. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Discomfort

  MAUDE report 15510404 ↗
• MalfunctionAug 17, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING HALF OF THE 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 15239397 ↗
• MalfunctionJul 19, 2022Break; Break

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED PRIOR TO USE THE STRING WAS BROKEN IN HALF ON A TAMPON. SINCE THIS WAS NOTICED PRIOR TO USE, SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15055743 ↗
• MalfunctionJul 8, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. 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 14957270 ↗
• MalfunctionJun 30, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF A TAMPON THE STRING WAS NOT ACCESSIBLE FOR REMOVAL OF THE PLEDGET FROM HER VAGINAL CAVITY BECAUSE IT WAS FOUND TO BE ON THE OPPOSITE END OF THE PLEDGET. SHE ALSO REPORTED PRIOR TO INSERTION OF THIS TAMPON SHE HAD NOTICED THE TAMPON STRING SEEMED SHORTER THAN NORMAL. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET FROM HER VAGINAL CAVITY AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT INDICATE EXPERIENCING ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14875210 ↗
• MalfunctionJun 15, 2022Material Separation; Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL A TAMPON FELL APART WHICH CAUSED HER PAIN. SHE HAD HER PARTNER HELP HER FINISH REMOVING 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: Pain

  MAUDE report 14705720 ↗
• MalfunctionJun 14, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE REMAINING PLEDGET PIECES AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14686215 ↗
• MalfunctionMay 27, 2022Material Separation; Material Separation

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

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14522079 ↗
• MalfunctionApr 5, 2022Difficult to Remove; Difficult to Remove

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE STRING COULD NOT BE FOUND TO AID IN REMOVING THE PLEDGET. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013527 ↗
• MalfunctionApr 5, 2022Difficult to Remove; Difficult to Remove

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE STRING COULD NOT BE FOUND TO AID IN REMOVING THE PLEDGET. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013500 ↗
• MalfunctionApr 5, 2022Difficult to Remove; Difficult to Remove

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE STRING COULD NOT BE FOUND TO AID IN REMOVING THE PLEDGET. SHE WAS ABLE TO MANUALLY REMOVE THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14013478 ↗
• MalfunctionMar 29, 2022Break; Break

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED UPON REMOVAL THE STRING BROKE FROM A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE 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 13938006 ↗