CONVERTORS 9575Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10885380153525), received between Feb 21, 2019 and Mar 20, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Manufacturing, Packaging or Shipping Problem” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 20, 2020Packaging Problem

  DURING SET UP AND OPENING FOR A SURGICAL CASE IN THE OPERATING ROOM, A SCRUB TECH IDENTIFIED A PROBLEM WITH MANUFACTURING PACKAGING OF SURGICAL GOWNS. THE INNER STERILE DUST COVER AROUND THE GOWN HAD BEEN SEALED IN THE OUTER PACKAGING WRAP ADHESIVE EDGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9859708 ↗
• MalfunctionApr 9, 2019Microbial Contamination of Device; Material Split, Cut or Torn

  SURGICAL GOWN HAD AN INTACT DUST COVER, BUT A TEAR IN THE STERILE BLUE WRAP/PAPER LABEL MAKING THE SURGICAL GOWN NON-STERILE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8495185 ↗
• MalfunctionFeb 21, 2019Manufacturing, Packaging or Shipping Problem

  THE DUST COVER WAS TAKEN OFF OF A STERILE GOWN TO OPEN IT ONTO THE OPERATIVE FIELD AND NOTICED THAT THE BLUE WRAP WAS NOT FULLY COVERING THE GOWN, THEREFORE MAKING THE GOWN CONTAMINATED. THE GOWN WITH IDENTIFYING PAPER WORK TO THE MANAGER. THIS IS NOT THE FIRST TIME THIS HAS HAPPENED. THE GOWNS ARE COMING FROM THE MANUFACTURER THIS WAY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8357205 ↗