Surity Female External Catheter 38011Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07333387056630), received between Apr 17, 2026 and Apr 17, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 17, 2026Insufficient Device Problem Information

  A FEMALE USER REPORTED ON THE MANUFACTURER'S FACEBOOK AD THAT "I ENDED UP IN ICU WITH A UTI!". THE MANUFACTURER HAS MADE 3 ATTEMPTS TO CONTACT THE USER, BUT THE USER DOES NOT RESPOND. THE ONLY INFORMATION THE MANUFACTURER HAS IS THE MESSAGE ON FACEBOOK.

  Patient problems: Urinary Tract Infection

  MAUDE report 24911274 ↗
• InjuryApr 17, 2026Patient-Device Incompatibility

  A FEMALE USER REPORTED ON THE MANUFACTURER´S FACEBOOK AD THAT "I HAVE AN. ALLERGIC REACTION TO THE CATHETER." WHEN THE MANUFACTURER CONTACTED THE USER AND SPOKE WITH HER, SHE FURTHER REPORTED THAT SHE HAD PLACED THE DEVICE ON THE OUTER LABIA AND DEVELOPED AN ITCHY RASH THAT COVERED HER PERINEUM. SHE DID NOT SEEK MEDICAL ATTENTION. SHE USED SOME OVER THE COUNTER "YEAST INFECTION CREAM" AND THE RASH HAS SINCE RESOLVED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 24909273 ↗