U By Kotex KOTEX TAMPONS (UDI 00036000515855)Recalls & reported problems

Summary

The FDA's MAUDE database contains 41 adverse event reports that list this exact device (DI 00036000515855), received between Dec 8, 2020 and Aug 10, 2026 — classified as 41 malfunctions.

The most frequently reported specific device problem is “Material Separation” (24 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 41 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 10, 2026Component Missing

  Consumer reported on behalf of his wife that upon removal of a tampon from her vaginal cavity, the string was missing. 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 50195021 ↗
• MalfunctionMay 13, 2026Material Separation

  NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A TAMPON, THE STRING FULLY SEPARATED FROM THE PLEDGET. SHE AND HER HUSBAND WERE UNSUCCESSFUL AT REMOVING THE PLEDGET MANUALLY FROM HER VAGINAL CAVITY SO SHE SOUGHT MEDICAL ATTENTION FOR REMOVAL. SHE DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Foreign Body In Patient

  MAUDE report 25159749 ↗
• MalfunctionAug 6, 2025Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED THAT THE TIP OF ALMOST ALL OF THE TAMPONS APPEARED PARTIALLY OPEN. SHE CONTINUED TO USE THEM AND REPORTED EXPERIENCING SOME PAIN AND DISCOMFORT UPON INSERTION. SHE STOPPED USING THE REMAINING TAMPONS. SHE DID NOT REQUIRE MEDICAL ASSISTANCE AND SHE DID NOT EXPERIENCE ANY SERIOUS ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 22725605 ↗
• MalfunctionJun 24, 2025Component Missing; Component Missing

  REPORT 2 OF 2. CONSUMER REPORTED THAT AFTER INSERTION OF A SUPER PLUS ABSORBENCY TAMPON, SHE REALIZED THE REMOVAL STRING WAS MISSING. SHE WAS ABLE TO REMOVE 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 22319091 ↗
• MalfunctionJun 24, 2025Component Missing; Component Missing

  REPORT 1 OF 2. CONSUMER REPORTED THAT AFTER INSERTION OF A SUPER PLUS ABSORBENCY TAMPON, SHE REALIZED THE REMOVAL STRING WAS MISSING. SHE WAS ABLE TO REMOVE 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 22319070 ↗
• MalfunctionJan 24, 2025Difficult to Remove; Difficult to Remove

  REPORT 2 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THAT A TAMPON WAS LOST OR DISLODGED INSIDE OF HER VAGINAL CAVITY. SHE DID NOT REPORT A SPECIFIC DATE OF EVENT. THERE WAS NO REPORT OF ANY MEDICAL ATTENTION BEING REQUIRED OR ANY EXPERIENCE OF AN ADVERSE HEALTH EFFECT. 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 21229008 ↗
• MalfunctionJan 24, 2025Difficult to Remove; Difficult to Remove

  REPORT 1 OF 2. NON-US EVENT; OCCURRED IN CANADA. CONSUMER REPORTED THAT A TAMPON WAS LOST OR DISLODGED INSIDE OF HER VAGINAL CAVITY. SHE REPORTED THAT SHE WAS IN THE EMERGENCY ROOM HAVING IT REMOVED. 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: Foreign Body In Patient

  MAUDE report 21228968 ↗
• MalfunctionJul 3, 2024Break; Break

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING BROKE. 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 19667739 ↗
• MalfunctionMar 18, 2024Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED UPON ATTEMPTED REMOVAL OF A TAMPON ON (B)(6) 2024, THE STRING WAS NOT ACCESSIBLE, AND SHE AND HER BOYFRIEND WERE UNABLE TO REMOVE THE PLEDGET. THE FOLLOWING DAY, ON (B)(6) 2024, SHE WENT TO THE EMERGENCY ROOM FOR REMOVAL OF THE PLEDGET FROM HER VAGINAL CAVITY. THE DOCTOR REPORTEDLY NOTED THE STRING WAS FOUND TO BE ON THE OPPOSITE END OF THE PLEDGET. THE CONSUMER REPORTED SYMPTOMS OF DISCHARGE AND CRAMPING AS WELL AS EXPERIENCING PAIN DURING THE PROCEDURE. SHE REPORTED THAT THE DOCTOR¿S OFFICE FAILED TO INFORM HER THAT THEY PRESCRIBED A MEDICATION FOR AN INFECTION, WHICH SHE WAS NOT AWARE OF THIS UNTIL ON (B)(6) 2024. SHE WAS UNSURE OF THE DIAGNOSIS, BUT THOUGHT IT WAS BACTERIAL VAGINOSIS. SHE WAS PRESCRIBED METRONIDAZOLE 500 MG TABLETS. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL DETAILS ARE OBTAINED.

  Patient problems: Cramp(s) /Muscle Spasm(s); Foreign Body In Patient; Pain

  MAUDE report 18926569 ↗
• MalfunctionDec 8, 2023Break; Break

  REPORT 5 OF 5. CONSUMER REPORTED UPON REMOVAL OF A 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 18292169 ↗
• MalfunctionDec 8, 2023Break; Break

  REPORT 4 OF 5. CONSUMER REPORTED UPON REMOVAL OF A 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 18292160 ↗
• MalfunctionDec 8, 2023Break; Break

  REPORT 3 OF 5. CONSUMER REPORTED UPON REMOVAL OF A 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 18292119 ↗
• MalfunctionDec 8, 2023Break; Break

  REPORT 2 OF 5. CONSUMER REPORTED UPON REMOVAL OF A 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 18292100 ↗
• MalfunctionDec 8, 2023Break; Break

  REPORT 1 OF 5. CONSUMER REPORTED UPON REMOVAL OF A 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 18291994 ↗
• MalfunctionNov 16, 2023Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET AND LEFT THE PLEDGET INSIDE HER VAGINAL CAVITY. SHE REPORTED WAITING A FULL DAY UNTIL THE PLEDGET WAS SATURATED AND THEN SHE VAGINALLY PUSHED THE PLEDGET OUT IN ONE PIECE. AFTER REMOVAL, SHE EXPERIENCED DISCOMFORT AND IRRITATION THAT LASTED FOR APPROXIMATELY ONE DAY. SHE USED EPSOM SALT BATHS AND IS FULLY RECOVERED. SHE DID NOT SEEK MEDICAL ATTENTION.

  Patient problems: Discomfort; Skin Inflammation/ Irritation

  MAUDE report 18150264 ↗
• MalfunctionOct 23, 2023Material Separation; Material Separation

  REPORT 3 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART INTO PIECES. SHE MANUALLY REMOVED PIECES FROM HER VAGINAL CAVITY. SHE WAS UNSURE IF SHE REMOVED THEM ALL SO SHE WAS SCHEDULING AN APPOINTMENT WITH HER DOCTOR TO CONFIRM NO PIECES REMAINED INSIDE OF HER. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL DETAILS ARE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 17985123 ↗
• MalfunctionOct 23, 2023Material Separation; Material Separation

  REPORT 2 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART INTO PIECES. SHE MANUALLY REMOVED PIECES FROM HER VAGINAL CAVITY. SHE WAS UNSURE IF SHE REMOVED THEM ALL SO SHE WAS SCHEDULING AN APPOINTMENT WITH HER DOCTOR TO CONFIRM NO PIECES REMAINED INSIDE OF HER. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL DETAILS ARE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 17985111 ↗
• MalfunctionOct 23, 2023Material Separation; Material Separation

  REPORT 1 OF 3. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE PLEDGET FELL APART INTO PIECES. SHE MANUALLY REMOVED PIECES FROM HER VAGINAL CAVITY. SHE WAS UNSURE IF SHE REMOVED THEM ALL SO SHE WAS SCHEDULING AN APPOINTMENT WITH HER DOCTOR TO CONFIRM NO PIECES REMAINED INSIDE OF HER. SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S OUTCOME; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED. IF ADDITIONAL DETAILS ARE OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

  Patient problems: Insufficient Information

  MAUDE report 17985099 ↗
• MalfunctionApr 20, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A 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 16775769 ↗
• MalfunctionApr 5, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS, THE PLEDGET FELL APART. SHE MANUALLY REMOVED 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 16681173 ↗
• MalfunctionApr 4, 2023Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS IN THE PAST, THE PLEDGET FELL APART. SHE MANUALLY REMOVED 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 16676210 ↗
• MalfunctionApr 4, 2023Component Missing; Component Missing

  PRIOR TO USE OF AN UNSPECIFIED NUMBER OF TAMPONS, THE CONSUMER REPORTED THAT THE STRING WAS MISSING. SHE DID NOT USE ANY OF THESE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16673403 ↗
• MalfunctionJan 12, 2023Material Separation; Material Separation

  CONSUMER REPORTED THAT UPON REMOVAL AN UNSPECIFIED NUMBER OF TAMPONS FELL APART. 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 16145708 ↗
• MalfunctionOct 5, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF AN UNSPECIFIED NUMBER OF TAMPONS BETWEEN (B)(6) 2022 AND (B)(6) 2022, THE PLEDGETS FELL APART. SHE MANUALLY REMOVED PLEDGET PIECES FROM HER VAGINAL CAVITY WHICH CAUSED VAGINAL PAIN. SHE ALSO WENT TO THE EMERGENCY ROOM AND ADDITIONAL PIECES OF PLEDGET WERE REMOVED WITH A SWAB. HER PAIN RESOLVED AND SHE DID NOT HAVE PLANS FOR ANY ADDITIONAL MEDICAL VISITS.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 15547465 ↗
• MalfunctionAug 3, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON THE PLEDGET FELL APART INTO TWO 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 15159706 ↗