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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00851906007149), received between Apr 24, 2025 and Apr 24, 2025 — classified as 1 malfunction.

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.

• MalfunctionApr 24, 2025Difficult to Remove; Patient Device Interaction Problem; Difficult to Remove; Patient Device Interaction Problem

  THE CUSTOMER REPORTED GOING TO THEIR DOCTOR FOR ASSISTANCE WITH REMOVAL OF A DISPOSABLE FLEX DISC. THE DISC HAD BEEN INSERTED FOR APPROXIMATELY 36 HOURS AT THE TIME OF THE ASSISTED REMOVAL. THE CUSTOMER INDICATED THAT THIS WAS THEIR FIRST TIME USING THE PRODUCT AND THEY WERE UNABLE TO REMOVE IT THEMSELVES. THEY STATED THAT THE DOCTOR COMPLETED REMOVAL WITHOUT THE USE OF ANY TOOLS AND THE CUSTOMER WAS NOT PRESCRIBED ANY MEDICATION. THE CUSTOMER FURTHER REPORTED THAT THE DOCTOR STATES THAT THE CUSTOMER'S PELVIC BONE MADE REMOVAL OF THE PRODUCT DIFFICULT. THE SUBMISSION OF THIS REPORT IS NOT AN ADMISSION BY THE COMPANY THAT THE USE OF THE DEVICE IN QUESTIONS CAUSED OR CONTRIBUTED TO THE CUSTOMER EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21905822 ↗