U By Kotex KOTEX TAMPONS (UDI 00036000515886)Recalls & reported problems

Summary

The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00036000515886), received between Sep 18, 2020 and Sep 22, 2026 — classified as 48 malfunctions.

The most frequently reported specific device problem is “Material Separation” (34 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 48 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  Non-US event; occurred in Canada. Consumer reported upon removal of a Regular absorbency tampon, the string broke. 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 50854992 ↗
• MalfunctionSep 19, 2025Difficult to Remove; Difficult to Remove

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A REGULAR ABSORBENCY TAMPON, THE STRING WAS SHORTER THAN USUAL. SHE WAS ABLE TO LOCATE AND USE THE STRING FOR REMOVAL OF 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 23098214 ↗
• MalfunctionAug 28, 2025Difficult to Insert; Difficult to Insert

  CONSUMER REPORTED UPON INSERTION OF AN UNSPECIFIED NUMBER OF TAMPONS, THE INSERTION TUBE BROKE APART. PART OF THE TUBE WAS LEFT INSIDE OF HER VAGINAL CAVITY AND SHE WAS ABLE TO MANUALLY REMOVE IT. SHE REPORTED IT BEING UNCOMFORTABLE. SHE DID NOT SEEK MEDICAL ATTENTION AND SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Discomfort

  MAUDE report 22917047 ↗
• MalfunctionJul 14, 2025Difficult to Remove; Difficult to Remove

  REPORT 5 OF 5. CONSUMER REPORTED VIA EMAIL ALLEGING THE TAMPON WAS STRING SIDE UP INSIDE THE APPLICATOR MAKING THE STRING NOT EASILY ACCESSIBLE OR SHORT WHEN IT WAS TIME FOR REMOVAL FROM HER VAGINAL CAVITY. SHE REPORTS THIS HAPPENED WITH AT LEAST 5 TAMPONS. 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 22493290 ↗
• MalfunctionJul 14, 2025Difficult to Remove; Difficult to Remove

  REPORT 4 OF 5. CONSUMER REPORTED VIA EMAIL ALLEGING THE TAMPON WAS STRING SIDE UP INSIDE THE APPLICATOR MAKING THE STRING NOT EASILY ACCESSIBLE OR SHORT WHEN IT WAS TIME FOR REMOVAL FROM HER VAGINAL CAVITY. SHE REPORTS THIS HAPPENED WITH AT LEAST 5 TAMPONS. 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 22493278 ↗
• MalfunctionJul 14, 2025Difficult to Remove; Difficult to Remove

  REPORT 3 OF 5. CONSUMER REPORTED VIA EMAIL ALLEGING THE TAMPON WAS STRING SIDE UP INSIDE THE APPLICATOR MAKING THE STRING NOT EASILY ACCESSIBLE OR SHORT WHEN IT WAS TIME FOR REMOVAL FROM HER VAGINAL CAVITY. SHE REPORTS THIS HAPPENED WITH AT LEAST 5 TAMPONS. 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 22493275 ↗
• MalfunctionJul 14, 2025Difficult to Remove; Difficult to Remove

  REPORT 2 OF 5. CONSUMER REPORTED VIA EMAIL ALLEGING THE TAMPON WAS STRING SIDE UP INSIDE THE APPLICATOR MAKING THE STRING NOT EASILY ACCESSIBLE OR SHORT WHEN IT WAS TIME FOR REMOVAL FROM HER VAGINAL CAVITY. SHE REPORTS THIS HAPPENED WITH AT LEAST 5 TAMPONS. 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 22493271 ↗
• MalfunctionJul 14, 2025Difficult to Remove; Difficult to Remove

  REPORT 1 OF 5. CONSUMER REPORTED VIA EMAIL ALLEGING THE TAMPON WAS STRING SIDE UP INSIDE THE APPLICATOR MAKING THE STRING NOT EASILY ACCESSIBLE OR SHORT WHEN IT WAS TIME FOR REMOVAL FROM HER VAGINAL CAVITY. SHE REPORTS THIS HAPPENED WITH AT LEAST 5 TAMPONS. 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 22493267 ↗
• MalfunctionApr 6, 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 14025894 ↗
• MalfunctionMar 4, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED THAT UPON REMOVAL OF MULTIPLE TAMPONS THE STRING UNRAVELED YET REMAINED ATTACHED TO THE PLEDGET WHILE THE TAMPONS 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 13667277 ↗
• MalfunctionFeb 22, 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 13578337 ↗
• MalfunctionFeb 22, 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 13578335 ↗
• MalfunctionFeb 22, 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 13578185 ↗
• MalfunctionFeb 7, 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 WAS ABLE TO REMOVE THE REMAINING PIECES OF PLEDGET AND DID NOT SEEK MEDICAL ATTENTION. SHE IS A REGISTERED PRACTICAL NURSE AND MONITORED FOR SYMPTOMS. SHE DID NOT SEEK ADDITIONAL MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13474381 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE 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 13344011 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE 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 13344002 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE 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 13343995 ↗
• MalfunctionJan 25, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE 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 13343992 ↗
• MalfunctionJan 19, 2022Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE 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 13289572 ↗
• MalfunctionJan 19, 2022Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL MULTIPLE TAMPONS FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO MANUALLY REMOVE 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 13289570 ↗
• MalfunctionJan 7, 2022Material 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 AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13192495 ↗
• MalfunctionJan 5, 2022Break; Difficult to Remove; Break; Difficult to Remove

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE INTO PIECES LEAVING THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE ATTEMPTED TO REMOVE THE PLEDGET FOR TWO TO THREE HOURS. SHE WAS FINALLY ABLE TO MANUALLY REMOVE THE 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 13170787 ↗
• MalfunctionDec 7, 2021Break; Material Separation; Break; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL THE STRING BROKE OFF OF A TAMPON AND WHEN REMOVING THE PLEDGET, THE PLEDGET FELL APART INTO PIECES. SHE ALSO EXPERIENCED VAGINAL PAIN WHILE REMOVING THE PLEDGET. SHE WAS ABLE TO MANUALLY REMOVE ALL THE PLEDGET PIECES. THE PAIN RESOLVED AFTER REMOVAL AND SHE DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 12956567 ↗
• MalfunctionOct 19, 2021Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE MANUALLY REMOVED THE PLEDGET PIECES AND INSERTED A DIFFERENT BRAND OF TAMPON. LATER THAT SAME DAY WHEN SHE REMOVED THIS TAMPON, A PIECE OF THE PREVIOUS PLEDGET WAS STUCK TO IT. SHE STATED SHE BELIEVED ALL THE PLEDGET PIECES WERE REMOVED AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12658474 ↗
• MalfunctionOct 18, 2021Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL A TAMPON UNRAVELED AND SHE WAS UNSURE IF PIECES REMAINED INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO REMOVE THE TAMPON AND DID NOT SEEK MEDICAL ATTENTION. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12649667 ↗