MEDLINE MSG5970Recalls & reported problems
Medline Industries, Inc. · GLOVE,SURG,SIGNATURE LTX,ESS,LTX,PF,7 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888277629745), received between Jun 6, 2026 and Aug 28, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Inadequacy of Device Shape and/or Size” (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
- Inadequacy of Device Shape and/or Size1
- Material Deformation1
- Material Puncture/Hole1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- Exposure to Body Fluids1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50508015 ↗MalfunctionJun 19, 2026Material Split, Cut or Torn
IT REPORTED "SURGEON REPORTED A BREAK IN STERILE FIELD DUE TO POOR MEDLINE GLOVES, CONCERNED THAT THIS POSSIBLE EXPOSED THE PATIENT AND SELF." MANY GLOVES TORE IN THE MIDDLE OF A PROCEDURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25566137 ↗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 25420699 ↗
Other Surgeon's gloves devices
- GAMMEX 20685275Ansell Healthcare Product · Surgeon'S Gloves2 recalls0 reports
- PROTEXIS 2D72PT65XCardinal Health 200, LLC · Surgeon's gloves1 recall2 reports
- GAMMEX 20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall1 report
- Medline Industries, Inc. DYNJ63673DMedline Industries, Inc. · Surgeon's gloves1 recall1 report
- GAMMEX 20685255Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685265Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- NOVAPLUS V20685290Ansell Healthcare Product · Surgeon'S Gloves1 recall0 reports
- GAMMEX 20685260Ansell Healthcare Product · 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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