U By Kotex KOTEX TAMPONS (UDI 00036000535327)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00036000535327), received between Jun 9, 2021 and May 20, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Material Separation” (19 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 20, 2026Material Separation

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THAT THE STRING FROM A REGULAR ABSORBENCY TAMPON SEPARATED FROM THE PLEDGET. SHE AND HER PARTNER WERE UNSUCCESSFUL AT REMOVING THE PLEDGET FROM HER VAGINAL CAVITY SO 24 HOURS LATER SHE HAD IT REMOVED AT A MEDICAL CLINIC. SHE EXPERIENCED AN IRRITATION AND BURNING SENSATION INSIDE, WHICH HAS SINCE IMPROVED. SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS. .

  Patient problems: Burning Sensation; Foreign Body In Patient; Skin Inflammation/ Irritation

  MAUDE report 25229287 ↗
• MalfunctionMay 4, 2026Break

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORT VIA EMAIL THAT WITH AN UNSPECIFIED NUMBER OF TAMPONS OVER THE LAST 2 YEARS, THE STRING DISINTEGRATED AND CAME OFF. SHE REPORTED BEING ABLE TO REMOVE THE PLEDGET FROM HER VAGINAL CAVITY WITHOUT MEDICAL ASSISTANCE. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS. 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 25067537 ↗
• MalfunctionNov 11, 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 20652318 ↗
• MalfunctionOct 18, 2024Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART. 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 20485531 ↗
• MalfunctionMar 6, 2024Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED VIA EMAIL THAT WHEN SHE OPENED A TAMPON FOR USE, SHE NOTED THAT THE TAMPON STRING WAS SHORT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OR NON-USE OF THE PRODUCT; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 18845046 ↗
• MalfunctionApr 6, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART 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 14026202 ↗
• MalfunctionApr 6, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART 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 14026177 ↗
• MalfunctionMar 17, 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 13802205 ↗
• MalfunctionFeb 7, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART INTO TWO PIECES LEAVING A PIECE INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE PIECE OF PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13472187 ↗
• MalfunctionJan 24, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THAT UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE TAMPON PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338444 ↗
• MalfunctionJan 24, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THAT UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE TAMPON PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338411 ↗
• MalfunctionJan 24, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THAT UPON REMOVAL THE STRING PULLED OUT OF A TAMPON LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE THE TAMPON PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13338317 ↗
• MalfunctionNov 4, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR APPROXIMATELY THREE HOURS AND UPON REMOVAL THE STRING PULLED OUT LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE TAMPON PLEDGET IN PIECES. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12751479 ↗
• MalfunctionNov 3, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON FOR APPROXIMATELY THREE HOURS AND UPON REMOVAL THE STRING PULLED OUT LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE TAMPON PLEDGET IN PIECES. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12749313 ↗
• MalfunctionOct 4, 2021Material 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 WAS ABLE TO MANUALLY REMOVE THE REMAINING PIECES OF 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 12568894 ↗
• MalfunctionOct 4, 2021Material 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 WAS ABLE TO MANUALLY REMOVE THE REMAINING PIECES OF 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 12568893 ↗
• MalfunctionOct 4, 2021Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED A TAMPON FELL APART INTO PIECES INSIDE HER VAGINAL CAVITY DURING USE. SHE WAS ABLE TO MANUALLY REMOVE THE REMAINING PIECES OF 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 12568885 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE REMAINING TAMPON 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 12478080 ↗
• MalfunctionSep 15, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE REMAINING TAMPON 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 12478072 ↗
• MalfunctionJun 9, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY ONE HOUR AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. AFTER THIS OCCURRED SHE EXPERIENCED VAGINAL PAIN AND BURNING. SHE WAS UNSURE IF SHE REMOVED THE REMAINING PLEDGET PIECES AND PLANNED TO SEEK MEDICAL ATTENTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 11966667 ↗
• MalfunctionJun 9, 2021Material Separation; Material Separation

  CONSUMER REPORTED SHE WORE A TAMPON APPROXIMATELY ONE HOUR AND UPON REMOVAL THE TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. AFTER THIS OCCURRED SHE EXPERIENCED VAGINAL PAIN AND BURNING. SHE WAS UNSURE IF SHE REMOVED THE REMAINING PLEDGET PIECES AND PLANNED TO SEEK MEDICAL ATTENTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME, HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Burning Sensation; Pain

  MAUDE report 11966655 ↗