MEDLINE INDUSTRIES, INC. NONLV325XLRecalls & reported problems
Medline Industries, Inc. · GOWN,ISO,LVL3,SMS,KNITCUFF,HOOKLP,BLU,XL · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 20080196765499), received between Sep 28, 2026 and Sep 28, 2026 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak5
Patient problems
- No Clinical Signs, Symptoms or Conditions5
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926675 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926674 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926673 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926670 ↗MalfunctionSep 28, 2026Fluid/Blood Leak
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926669 ↗
Other Gown, isolation, surgical devices
- CARDINAL HEALTH AT6588-2XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6200-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6588-BDCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6588-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6688-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6688-BDCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6100-XLCardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
- CARDINAL HEALTH AT6100Cardinal Health 200, LLC · Gown, isolation, surgical1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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