MEDLINE MSG6365Recalls & reported problems
Medline Industries, Inc. · GLOVE,SURG,SENSICARE NEOPRENE,LF,PF,6.5 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10193489000030), received between Feb 12, 2026 and Sep 24, 2026 — classified as 8 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (7 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn7
- Material Puncture/Hole1
- Patient Device Interaction Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
- Exposure to Body Fluids1
- Itching Sensation1
- Skin Inflammation/ Irritation1
- Swelling/ Edema1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 24, 2026Material Split, Cut or Torn
It was reported that gloves break easily during use, when a small perforation is made, it extends and enlarges along the length of the glove. Mainly breaks in the area of the fingertips are reported.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50888466 ↗MalfunctionSep 18, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50829497 ↗MalfunctionSep 9, 2026Material Puncture/Hole; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697694 ↗MalfunctionSep 7, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650175 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564420 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
It was reported that "The concern is that the glove ripped during the procedure."
Patient problems: Exposure to Body Fluids
MAUDE report 50548806 ↗MalfunctionAug 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532392 ↗MalfunctionFeb 12, 2026Patient Device Interaction Problem
ACCORDING TO THE CUSTOMER, THE INDIVIDUAL EXPERIENCED "REDNESS, ITCHING, AND SWELLING" BEGINNING IN THE "SUMMER OF 2025" WHILE USING THE GLOVES. THE CUSTOMER REPORTED THAT THE IRRITATION OCCURRED "ON AND OFF" WHILE USING THE PRODUCT BUT WORSENED IN (B)(6) OF 2026 CAUSING THE INDIVIDUAL TO SEEK MEDICAL ATTENTION.
Patient problems: Itching Sensation; Skin Inflammation/ Irritation; Swelling/ Edema
MAUDE report 24322310 ↗
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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