Flex Box of Flex 12 count (English only) VERTICALRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00851906007248), received between Oct 12, 2023 and Jul 15, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 15, 2026Difficult to Remove; Patient Device Interaction Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25830540 ↗
• MalfunctionJun 11, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED GOING TO THE EMERGENCY ROOM FOR ASSISTANCE WITH REMOVAL OF A DISPOSABLE MENSTRUAL DISC. THE PROVIDER ALSO HAD DIFFICULTY REMOVING THE CUP. IMAGING WAS USED TO LOCATE THE DISC. CUSTOMER STATED TOOLS WERE USED AND PAIN OCCURRED DURING THE REMOVAL PROCESS. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 22186556 ↗
• MalfunctionJun 11, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED GOING TO THE URGENT CARE FOR ASSISTANCE WITH REMOVAL OF A DISPOSABLE MENSTRUAL DISC. THE URGENT CARE PROVIDER ALSO HAD DIFFICULTY REMOVING THE CUP. CUSTOMER STATED TOOLS WERE USED AND PAIN OCCURRED DURING THE REMOVAL PROCESS. CUSTOMER USED ADVIL FOR THE PAIN BUT WAS NOT PRESCRIBED ANY MEDICATION BY THE URGENT CARE. PAIN SUBSIDED AFTER A DAY OR TWO. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: Pain

  MAUDE report 22186554 ↗
• MalfunctionMar 27, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  CUSTOMER REPORTED GOING TO URGENT CARE FOR ASSISTANCE WITH REMOVAL OF FLEX DISPOSABLE DISC. CUSTOMER STATED THE DISC WAS INSERTED ON FEBRUARY 15TH. CUSTOMER TRIED TO REMOVE THE DISC MULTIPLE TIMES OVER THE NEXT SEVERAL DAYS. CUSTOMER WENT TO URGENT CARE FOR ASSISTANCE WITH REMOVAL ON FEBRUARY 21ST. THE CUSTOMER STATED THE URGENT CARE DOCTOR WAS UNABLE TO REMOVE THE DISC AND THE CUSTOMER WAS SENT TO THE ER FOR FURTHER EVALUATION. THE DISC WAS SUCCESSFULLY REMOVED BY THE ER DOCTOR AT 2:30AM ON FEBRUARY 22ND. THE DISC HAD BEEN INSERTED FOR APPROXIMATELY 151 HOURS TOTAL BEFORE IT WAS SUCCESSFULLY REMOVED BY THE DOCTOR. THE CUSTOMER STATED THE DOCTOR USED TOOLS TO ASSIST WITH REMOVAL BUT DID NOT SPECIFY WHICH. THE CUSTOMER REPORTED SOME DISCOMFORT POST REMOVAL BUT WAS NOT PRESCRIBED ANY MEDICATION. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21715643 ↗
• MalfunctionNov 15, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER LEFT A REVIEW ON THE COMPANY'S WEBSITE TO REPORT THAT THEY HAD EXPERIENCED DIFFICULTY REMOVING THE DEVICE AND SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT A LOCAL WOMEN'S URGENT CARE CLINIC. THIS WAS THE FIRST TIME THE CUSTOMER USED THE DEVICE, AND IT WAS IN PLACE FOR APPROXIMATELY 20 HOURS BEFORE BEING REMOVED. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER ALSO EXPERIENCED DIFFICULTY REMOVING THE DEVICE, BUT WAS EVENTUALLY ABLE TO REMOVE THE DEVICE USING FORCEPS. THE CUSTOMER STATED THAT THEY HAVE A TILTED UTERUS, AND WAS INFORMED BY THE MEDICAL PROVIDER THAT REMOVED THE DEVICE THAT THEY HAVE A HIGH CERVIX. THE CUSTOMER STATED THAT THEY HAD SOME MILD CRAMPING BEFORE REMOVAL, BUT DID NOT REPORT EXPERIENCING ANY ADVERSE SYMPTOMS DURING OR AFTER REMOVAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND FOLLOW UP WITH THEIR PRIMARY CARE PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18145689 ↗
• MalfunctionOct 12, 2023Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER CONTACTED THE COMPANY'S CUSTOMER EXPERIENCE TEAM VIA EMAIL TO REPORT THAT THEY HAD EXPERIENCED DIFFICULTY REMOVING THE DEVICE AND SOUGHT MEDICAL ASSISTANCE FOR REMOVAL AT A LOCAL URGENT CARE. THIS WAS THE FIRST TIME THE CUSTOMER USED THE DEVICE, AND IT WAS IN PLACE FOR APPROXIMATELY 19 HOURS BEFORE BEING REMOVED. THE CUSTOMER STATED THAT THEIR TREATING PROVIDER ALSO EXPERIENCED DIFFICULTY REMOVING THE DEVICE. THE CUSTOMER DID NOT REPORT EXPERIENCING ANY ADVERSE SYMPTOMS DURING OR AFTER REMOVAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND FOLLOW UP WITH THEIR PRIMARY CARE PROVIDER. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTION CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17923310 ↗