MEDLINE NONTH180Recalls & reported problems
Medline Industries, Inc. · GOWN,POLY,OVRHD,THUMBLOOP,BLUE,UNI · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 30884389161184), received between Sep 18, 2026 and Sep 18, 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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn1
Patient problems
- Exposure to Body Fluids1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Split, Cut or Torn
Patient problems: Exposure to Body Fluids
MAUDE report 50830008 ↗
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- Halyard 69600O&M Halyard, Inc. · Non-surgical isolation gown2 reports
- CARDINAL HEALTH 2202CVCardinal Health 200, LLC · Non-surgical isolation gown1 report
- MEDLINE NONTH150Medline Industries, Inc. · Non-surgical gown1 report
- EndoArmor™ Plus SGE-389-10Boston Scientific Corporation · Non-surgical isolation gown1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.