Sunny Menstrual Cup and Applicator Size 1 SUNAC011PEGI01Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00860009638617), received between Jan 26, 2026 and Jan 26, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Difficult to Remove” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2026Difficult to Remove; Patient-Device Incompatibility; Insufficient Device Problem Information; Patient Device Interaction Problem

  ON JANUARY 6, 2026 SUNNY WAS MADE AWARE OF A CUSTOMER COMPLAINT VIA EMAIL. THE CUSTOMER CLAIMED THAT WHILE USING THE SUNNY CUP + APPLICATOR, THEIR CUP BECAME STUCK AND THEY HAD TO SEEK MEDICAL CARE AT URGENT CARE TO HAVE IT REMOVED. THIS CUSTOMER ALSO NOTED THAT THEY HAVE PHYSICAL CONSTRAINTS, INCLUDING HYPERMOBILITY ISSUES AND A HIGH CERVIX, THAT MAKE REACHING THE INSERTED CUP DIFFICULT. ONCE SUNNY BECAME AWARE OF THIS EVENT, THEY REACHED OUT TO THE CUSTOMER 2 TIMES (JANUARY 7, 2026, AND JANUARY 14, 2026) FOR MORE INFORMATION. THE CUSTOMER HAS NOT YET RESPONDED. NO FURTHER INFORMATION ABOUT THE EVENT IS AVAILABLE. SUNNY BELIEVES THE INSTRUCTIONS GIVEN IN THE INSTRUCTIONS FOR USE ARE AN ADEQUATE DIRECTIVE FOR THE REMOVAL OF THE MENSTRUAL CUP. THE IFU STATES: "LOCATE THE BASE OF YOUR CUP" "IF YOU CANNOT REACH IT, GENTLY PUSH LIKE YOU'RE HAVING A BOWEL MOVEMENT" "USE THE STEM AS A GUIDE UNTIL YOU CAN REACH THE BASE OF YOUR CUP. PINCH THE BASE OF YOUR CUP TO BREAK THE SEAL. WITH THE BASE PINCHED, GENTLY PULL DOWN TO REMOVE YOUR CUP." THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 24180125 ↗