U By Kotex KOTEX TAMPONS (UDI 00036000515862)Recalls & reported problems

Summary

The FDA's MAUDE database contains 126 adverse event reports that list this exact device (DI 00036000515862), received between Nov 13, 2020 and Jul 21, 2026 — classified as 1 injury, 125 malfunctions.

The most frequently reported specific device problem is “Material Separation” (104 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.

• MalfunctionJul 21, 2026Material Separation

  Patient problems: Insufficient Information

  MAUDE report 25889097 ↗
• MalfunctionJun 1, 2026Material Separation

  REPORT 2 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING 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 25348226 ↗
• MalfunctionJun 1, 2026Material Separation

  REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. SHE MANUALLY REMOVED THE REMAINING 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 25348184 ↗
• MalfunctionApr 27, 2026Material Separation

  CONSUMER REPORTED THAT THE STRING FROM A TAMPON DETACHED IN ONE PIECE FROM THE PLEDGET DURING INSERTION, WHILE PULLING OUT THE APPLICATOR FROM HER BODY. SHE MANUALLY REMOVED THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24997796 ↗
• MalfunctionMar 24, 2026Product Quality Problem

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED VIA EMAIL THAT WHEN SHE PUT A TAMPON IN, THERE WERE SOME PIECES OF PLASTIC INSIDE 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: Insufficient Information

  MAUDE report 24680444 ↗
• MalfunctionMar 16, 2026Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET. SHE WAS UNABLE TO REMOVE THE PLEDGET HERSELF, SO SHE WENT TO URGENT CARE FOR MEDICAL ASSISTANCE FOR REMOVAL OF THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 24604154 ↗
• MalfunctionMar 11, 2026Product Quality Problem

  CONSUMER REPORTED THAT AFTER INSERTION OF A TAMPON AND REMOVAL OF THE APPLICATOR, SHE NOTICED A PIECE OF PLASTIC PLEDGET WRAP ATTACHED TO THE APPLICATOR. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS OR THE NEED FOR MEDICAL ATTENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24570538 ↗
• MalfunctionDec 9, 2025Break; Break

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. HER HUSBAND ASSISTED WITH REMOVAL OF THE PLEDGET FROM HER VAGINAL CAVITY. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT REPORT ANY SERIOUS ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23759872 ↗
• MalfunctionNov 4, 2025Break; Break

  CONSUMER REPORTED THAT PRIOR TO USE OF AN UNSPECIFIED NUMBER OF TAMPONS, SHE TUGGED ON THE STRING AND THE STRING BROKE INTO TWO PIECES. SHE DID NOT USE THE PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23465279 ↗
• MalfunctionAug 19, 2025Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED, UPON ATTEMPTED REMOVAL OF A TAMPON, SHE WAS NOT ABLE TO USE THE STRING BECAUSE IT WAS TOO SHORT TO GRASP SO SHE MANUALLY REMOVED THE TAMPON 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 22842362 ↗
• MalfunctionJun 26, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A REGULAR ABSORBENCY TAMPON, THE PLEDGET FELL APART INTO TWO PIECES. 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 22340627 ↗
• MalfunctionOct 22, 2024Difficult to Remove; Difficult to Remove

  REPORT 1 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING WAS TOO SHORT TO GRASP. SHE MANUALLY REMOVED THE TAMPON 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 20509798 ↗
• MalfunctionOct 22, 2024Difficult to Remove; Difficult to Remove

  REPORT 2 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING WAS TOO SHORT TO GRASP. SHE MANUALLY REMOVED THE TAMPON 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 20509555 ↗
• MalfunctionOct 16, 2024Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED FINDING A PIECE OF CLEAR PLASTIC WITH YELLOW STRIPES IN HER VAGINAL CAVITY. SHE DISCOVERED IT AND MANUALLY REMOVED IT SEVERAL DAYS AFTER HER MENSTRUAL CYCLE WAS OVER. 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 20467610 ↗
• MalfunctionSep 30, 2024Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED AFTER REMOVAL OF A TAMPON FROM HER VAGINAL CAVITY, A PIECE OF PLASTIC ALSO CAME OUT. 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 20334524 ↗
• MalfunctionAug 27, 2024Material Separation; Material Separation

  CONSUMER REPORTED THAT AFTER INSERTION OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET WHEN SHE REMOVED THE APPLICATOR FROM HER VAGINAL CAVITY. SHE USED A TWEEZERS TO REMOVE THE PLEDGET FROM INSIDE OF HER. 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 20074811 ↗
• MalfunctionJun 24, 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 IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19594530 ↗
• MalfunctionMay 2, 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 IN ONE PIECE. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228448 ↗
• MalfunctionMay 2, 2024Material Separation; Material Separation

  THE CONSUMER REPORTED THAT PRIOR TO USE OF A TAMPON, SHE PULLED SLIGHTLY ON THE STRING ACCORDING TO THE USAGE INSTRUCTIONS ON THE INSERT IN THE TAMPON CARTON. SHE NOTED THE STRING DETACHED FROM THE PLEDGET. SHE PROCEEDED TO TEST ADDITIONAL TAMPON STRINGS FROM THAT CARTON, ALLEGING THAT A TOTAL OF 4 STRINGS DETACHED PRIOR TO USE. THERE WAS NO HARM REPORTED AS SHE DID NOT USE ANY OF THESE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228431 ↗
• InjuryMay 2, 2024Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR 8 HOURS AND UPON REMOVAL ON (B)(6) 2024, THE STRING SEPARATED FROM THE PLEDGET. SHE ATTEMPTED TO REMOVE THE PLEDGET AND A PIECE OF PLEDGET BROKE OFF AND REMAINED INSIDE OF HER. SHE WAS UNABLE TO REMOVE THE REMAINING PIECE AND ON THE SAME DAY, (B)(6) 2024, SHE WENT TO THE EMERGENCY ROOM FOR REMOVAL. THE CONSUMER REPORTED EXPERIENCING A FEVER, ABDOMINAL PAIN, NAUSEA, AND VOMITING. SHE REPORTED THAT THE EMERGENCY ROOM PROVIDER FELT THAT SHE HAD THE START OF TSS, PRESCRIBED HER AMOXICILLIN AND ADMINISTERED A DOSE OF AMOXICILLIN IN THE EMERGENCY ROOM. SHE REPORTS SHE WAS INSTRUCTED TO RETURN TO THE EMERGENCY ROOM IF HER SYMPTOMS WORSENED. AS OF HER REPORTING ON (B)(6) 2024, THE CONSUMER STILL HAD A FEVER AND SOME ABDOMINAL CRAMPING, BUT WAS UNSURE IF IT WAS RELATED TO HER PERIOD. 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: Abdominal Pain; Fever; Foreign Body In Patient; Nausea; Vomiting

  MAUDE report 19228425 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  REPORT 3 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING DIDN¿T FEEL SECURE SO SHE DECIDED TO REMOVE THE PLEDGET WITHOUT THE STRING AND 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 19031308 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING DIDN¿T FEEL SECURE SO SHE DECIDED TO REMOVE THE PLEDGET WITHOUT THE STRING AND 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 19031248 ↗
• MalfunctionApr 3, 2024Material Separation; Material Separation

  REPORT 1 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING DIDN¿T FEEL SECURE SO SHE DECIDED TO REMOVE THE PLEDGET WITHOUT THE STRING AND 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 19031223 ↗
• MalfunctionFeb 21, 2024Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL OF A TAMPON, THE PLEDGET UNRAVELED AND FELL APART INTO TWO PIECES. THE REMAINING PIECE OF PLEDGET WAS REMOVED 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 18746702 ↗
• MalfunctionJan 24, 2024Break; Material Separation; Break; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING EITHER BROKE OR COMPLETELY DETACHED FROM THE PLEDGETS. SHE MANUALLY REMOVED THE PLEDGETS 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 18570296 ↗