NA 5820010060Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04546540414076), received between Jun 10, 2025 and Jun 10, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Difficult to Open or Remove Packaging Material” (3 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 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.

• MalfunctionJun 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175177 ↗
• MalfunctionJun 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  NO NEW INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175176 ↗
• MalfunctionJun 10, 2025Difficult to Open or Remove Packaging Material; Difficult to Open or Remove Packaging Material

  IT WAS REPORTED THAT THE BUR PACKAGING WAS NOT OPENING CORRECTLY, LEADING TO THE CONTAMINATION OF STERILE GLOVES. IT WAS ALSO REPORTED THAT THERE WERE NO ADVERSE CONSEQUENCES, NO MEDICAL INTERVENTION AND A CLINICALLY INSIGNIFICANT DELAY AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22175169 ↗