U By Kotex KOTEX TAMPONS (UDI 00036000535310)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00036000535310), received between Jan 28, 2022 and Jul 1, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 1, 2026Break

  CONSUMER REPORTED VIA SOCIAL MEDIA THAT THE STRING FROM A TAMPON BROKE. SHE ALLEGED SEEKING UNSPECIFIED MEDICAL SERVICES TO HAVE THE PLEDGET REMOVED. NO SYMPTOMS WERE REPORTED. 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 25677743 ↗
• MalfunctionJan 28, 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 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 13386636 ↗
• MalfunctionJan 28, 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 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 13386517 ↗
• MalfunctionJan 28, 2022Material Separation; Material Separation

  THIS IS A NON-US EVENT. THIS OCCURRED IN CANADA. CONSUMER REPORTED UPON REMOVAL A TAMPON FELL APART LEAVING PIECES INSIDE HER VAGINAL CAVITY. SHE WAS ABLE TO 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 13386027 ↗