MEDLINE MDS195176Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00080196764085), received between Aug 12, 2026 and Aug 12, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionAug 12, 2026Material Split, Cut or Torn

  It was reported that, customer stated that gloves ripped several times during patient care and really bad quality. She stated that she got bowel all over hands, which delayed from providing proper care and timing with cleaning him up. The customer stopped to cleanse hands and got some more gloves, better quality.

  Patient problems: Exposure to Body Fluids

  MAUDE report 50217160 ↗