MEDLINE MSG6380Recalls & reported problems
Medline Industries, Inc. · GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,8.0 · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10193489000061), received between May 7, 2026 and Sep 28, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn2
- Inadequacy of Device Shape and/or Size1
- Material Deformation1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Exposure to Body Fluids1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 28, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923503 ↗MalfunctionSep 28, 2026Material Puncture/Hole; Material Split, Cut or Torn
It was reported that "THEY HAVE OPENED 2 OF THE BOXES OF GLOVES SO FAR AND BOTH HAVE HAD GLOVES WITH HOLES IN THEM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50915556 ↗MalfunctionJun 6, 2026Inadequacy of Device Shape and/or Size; Material Deformation
IT WAS REPORTED THAT, CONCERN REPORTED BY THE SURGEON ABOUT THE INFERIOR QUALITY OF THE NEW SURGICAL GLOVES THAT ARE BEING PROVIDED. PER SURGEON REPORT, THE NEW REQUIRED SURGICAL GLOVES DO NOT FUNCTION APPROPRIATELY. THEY SLIDE DOWN ON THE FOREARMS ALLOWING STRIKE THROUGH OF PATIENT BLOOD DIRECTLY ONTO THE SKIN OF THE SURGEON'S DISTAL FOREARMS. IN ADDITION, THEY ARE SLIPPERY AND INTERFERE WITH TACTILITY AND SIZES ARE INCONSISTENT. THE FINGERTIPS STRETCH OUT AND BECOME LOOSE WHILE OTHER PORTIONS OF THE GLOVE DO NOT, MAKING FOR A VERY POOR SURGICAL EXPERIENCE. THESE GLOVES ARE NOT UP TO THE QUALITY NEEDED FOR PATIENT CARE AND SAFETY OF BOTH PATIENTS AND OR STAFF AND SURGEONS.
Patient problems: Exposure to Body Fluids
MAUDE report 25420703 ↗MalfunctionMay 7, 2026
SURGEON REPORTED THAT THE NEW GLOVES ARE UNACCEPTABLE. THEY HAVE A SLIMY TEXTURE THAT MAKES IT DIFFICULT TO TIE KNOTS. THE CUFFS ARE TOO LOOSE AND WORK THEIR WAY DOWN WHILE OPERATING. THEY HAVE A TRULY OFFENSIVE ODOR.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113933 ↗
Other Surgeon's gloves devices
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- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- NOVAPLUS V20685275Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685280Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- PROTEXIS 2D72PL65XCardinal Health 200, LLC · Surgeon's gloves1 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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