U By Kotex KOTEX TAMPONS (UDI 00036000515879)Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 00036000515879), received between Oct 16, 2020 and Mar 16, 2026 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Material Separation” (14 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 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2026Break

  REPORT 2 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE IN TWO PIECES. 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 24604074 ↗
• MalfunctionMar 16, 2026Break

  REPORT 1 OF 2. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE IN TWO PIECES. 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 24604070 ↗
• MalfunctionOct 15, 2025Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING SEPARATED FROM THE PLEDGET IN ONE PIECE. SHE WENT TO THE EMERGENCY ROOM ON THE SAME EVENING FOR REMOVAL OF THE PLEDGET FROM HER VAGINAL CAVITY. SINCE THE REMOVAL SHE REPORTS HAVING CRAMPS BUT ISN'T SURE IF IT'S FROM THIS ISSUE. SHE REPORTED HAVING NO FURTHER MEDICAL FOLLOW-UPS AND NO EXPERIENCE OF SERIOUS ADVERSE EVENTS.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 23293440 ↗
• MalfunctionSep 11, 2025Material Separation; Material Separation

  CONSUMER REPORTED VIA EMAIL THAT SHE NOTICED WITH AN UNSPECIFIED NUMBER OF TAMPONS, THE TIP OF THE PLEDGET WAS SHEDDING. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE CONSUMER¿S USE OF THE PRODUCT AND OUTCOME OR TO DETERMINE IF THIS WAS PRIOR TO USE; HOWEVER, NO FURTHER INFORMATION HAS BEEN RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 23025637 ↗
• MalfunctionSep 5, 2024Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT WITH AN UNSPECIFIED NUMBER OF TAMPONS, THE STRING WAS UNATTACHED. 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 20144442 ↗
• MalfunctionMay 3, 2024Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED VIA E-MAIL THAT UPON OPENING A TAMPON WRAPPER, SHE NOTICED THE TAMPON AND APPLICATOR WERE CUT IN HALF WITH ONLY THE BOTTOM HALF BEING PRESENT. SHE CONTINUED TO USE THE TAMPON AND WORE IT FOR 2 HOURS. UPON REMOVAL, 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 19238148 ↗
• MalfunctionMar 27, 2024Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED THAT THE STRING ON A TAMPON WAS NOT EASILY ACCESSIBLE FOR REMOVAL. SHE ALLEGED THAT THE TAMPON WAS PACKAGED WITH THE STRING ON THE WRONG SIDE. 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 18985730 ↗
• MalfunctionJan 9, 2024Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING WAS NOT ACCESSIBLE. SHE WAS UNABLE TO REMOVE THE PLEDGET. THE FOLLOWING MORNING SHE HAD HER DOCTOR REMOVE THE PLEDGET FROM HER VAGINAL CAVITY AND NOTED THE STRING WAS PRESENT BUT WRAPPED AROUND THE PLEDGET. SHE TOOK IBUPROFEN FOR VAGINAL CRAMPING AND PAIN THAT SHE EXPERIENCED FOR APPROXIMATELY A DAY AFTER REMOVAL.

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

  MAUDE report 18474931 ↗
• MalfunctionOct 24, 2023Break; Break

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. THE REMAINING PIECE OF STRING WAS STILL ATTACHED TO THE PLEDGET AND IT WAS LONG ENOUGH THAT SHE WAS ABLE TO USE IT FOR REMOVAL OF 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 17997125 ↗
• MalfunctionOct 24, 2023Difficult to Remove; Difficult to Remove

  CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING WAS SHORT. SHE WAS ABLE TO REMOVE THE PLEDGET WITH THE SHORT STRING HOWEVER SHE SCRATCHED HERSELF WHILE DOING SO. SHE CONSULTED WITH HER DOCTOR OVER THE PHONE AND NO EXAMS OR TREATMENTS WERE NEEDED. SHE REPORTED THAT BY THE NEXT DAY THE ISSUE WITH THE SCRATCH WAS RESOLVED.

  Patient problems: Abrasion

  MAUDE report 17997124 ↗
• MalfunctionSep 28, 2023Break; Break

  REPORT 3 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. SHE WAS ABLE TO USE THE REMAINING PIECE OF STRING 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 17834866 ↗
• MalfunctionSep 28, 2023Break; Break

  REPORT 1 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. SHE WAS ABLE TO USE THE REMAINING PIECE OF STRING 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 17834488 ↗
• MalfunctionSep 28, 2023Break; Break

  REPORT 2 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL OF A TAMPON, THE STRING BROKE. SHE WAS ABLE TO USE THE REMAINING PIECE OF STRING 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 17834304 ↗
• MalfunctionJun 23, 2023Material 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 SHE DID NOT REPORT ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17189911 ↗
• MalfunctionFeb 22, 2023Difficult to Remove; Difficult to Remove

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED THAT PRIOR TO USE OF AN UNSPECIFIED NUMBER OF TAMPONS IN THE PAST, THE STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16422582 ↗
• MalfunctionFeb 22, 2023Difficult to Remove; Difficult to Remove

  REPORT 2 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED THAT PRIOR TO USE OF AN UNSPECIFIED NUMBER OF TAMPONS THE STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421765 ↗
• MalfunctionFeb 22, 2023Difficult to Remove; Difficult to Remove

  REPORT 1 OF 3. THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED THAT PRIOR TO USE OF A TAMPON ON (B)(6) 2023 THE STRING APPEARED TO BE SHORT. SHE DID NOT USE THE TAMPON.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16421678 ↗
• MalfunctionSep 13, 2022Break; Break

  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 EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15411496 ↗
• MalfunctionMay 10, 2022Material Separation; Material Separation

  CONSUMER REPORTED UPON REMOVAL AN UNSPECIFIED NUMBER OF SUPER ABSORBENCY TAMPONS FELL APART. SHE MANUALLY REMOVED THE 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 14348976 ↗
• MalfunctionMay 10, 2022Material Separation; Material Separation

  CONSUMER REPORTED VIA E-MAIL THAT UPON REMOVAL AN UNSPECIFIED NUMBER OF TAMPONS FELL APART. 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 14348905 ↗
• MalfunctionFeb 25, 2022Product Quality Problem; Product Quality Problem

  CONSUMER REPORTED ON BEHALF OF HER DAUGHTER THAT UPON INSERTING MULTIPLE TAMPONS, THE APPLICATOR PETALS OPENED AND CAUSED PAIN. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 13599215 ↗
• MalfunctionFeb 17, 2022Material Fragmentation; Material Fragmentation

  CONSUMER REPORTED THAT PIECES OF THE INSERTION TUBE HAD BROKEN OFF AND WERE LEFT BEHIND INSIDE HER VAGINAL CAVITY AFTER INSERTING A TAMPON. SHE REPORTED SHE FELT A PINCH UPON INSERTING THE TAMPON AND WHILE REMOVING THE INSERTION TUBE SHE FELT A SHARP PAIN. AFTER INSERTION SHE NOTICED THE TOP OF THE INSERTION TUBE LOOKED BROKEN AND THE PETALS WERE MISSING. SHE THEN FELT SHARP PIECES OF THE INSERTION TUBE INSIDE HER VAGINAL CAVITY. SHE WAS UNABLE TO REMOVE THE INSERTION TUBE PIECES ON HER OWN. SHE EXPERIENCED CONTINUED DISCOMFORT AND WENT TO THE ER THE NEXT DAY. THE ER DOCTOR REMOVED FOUR OF FIVE PIECES OF INSERTION TUBE. SHE WAS PRESCRIBED NAPROXEN FOR HER DISCOMFORT. SHE DID NOT RECEIVE ANY ADDITIONAL MEDICAL TREATMENT AND HER SYMPTOMS WERE IMPROVING.

  Patient problems: Discomfort; Foreign Body In Patient; Pain

  MAUDE report 13549653 ↗
• MalfunctionJan 4, 2022Difficult to Remove; Material Separation; Difficult to Remove; Material Separation

  CONSUMER REPORTED SHE USED A TAMPON AND THOUGHT IT HAD COME OUT ON IT'S OWN AS SHE WAS UNABLE TO FIND THE TAMPON STRING TO REMOVE THE PLEDGET. SHE BEGAN EXPERIENCING VAGINAL CRAMPING AND A FOUL VAGINAL ODOR. APPROXIMATELY TWO WEEKS AFTER HER PERIOD ENDED, SHE FELT AROUND INSIDE HER VAGINAL CAVITY AND FOUND THE TAMPON PLEDGET STUCK SIDEWAYS. SHE MANUALLY REMOVED THE DISINTEGRATING PLEDGET AND NO STRING WAS FOUND. SHE BELIEVED SHE WAS ABLE TO REMOVE THE REMAINING PIECES OF PLEDGET. AFTER REMOVAL HER VAGINAL ODOR RESOLVED AND HER CRAMPING IMPROVED. SHE DID NOT SEEK MEDICAL ATTENTION AND DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 13157817 ↗
• MalfunctionSep 15, 2021Sharp Edges; Sharp Edges

  THIS IS A NON-US EVENT. THIS OCCURRED IN (B)(6). CONSUMER REPORTED SHE HAD A TAMPON THAT HAD AN APPLICATOR WITH A DEFORMED PETAL THAT WAS STICKING OUT AND SHARP. SHE DID NOT NOTICE PRIOR TO INSERTION AND WHEN ATTEMPTING TO INSERT, THE APPLICATOR COLLAPSED AND SHE WAS UNABLE TO INSERT THE PLEDGET INTO HER VAGINAL CAVITY. SHE FELT PAIN AND WHEN SHE REMOVED THE APPLICATOR SHE NOTICED ONE OF THE PETALS WAS SPLIT OR TORN, STICKING OUT AND SHARP. SHE THEN REALIZED THE PETAL CAUSED A SMALL CUT TO THE OPENING OF HER VAGINA. SHE PUT A PAD ON AND DID NOT WEAR TAMPONS FOR A FEW DAYS. SHE FELT SORENESS AFTER WHICH RESOLVED AND SHE DID NOT SEEK MEDICAL ATTENTION. CONSUMER DID NOT EXPERIENCE ANY ADVERSE HEALTH EFFECTS.

  Patient problems: Pain

  MAUDE report 12478253 ↗
• MalfunctionAug 18, 2021Material 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 PIECES 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 12337936 ↗