MEDLINE MSG9080Recalls & reported problems
Medline Industries, Inc. · GLOVE,SURG,SENSICARE PI,LF,PF,8.0 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10888277347915), received between Aug 31, 2026 and Sep 30, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn5
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions6
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
It was reported that "Glove tore while CST was doffing his glove during evaluation table top. Cuff of the glove tore completely off the palm/finger portion of the glove."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945693 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
It was reported that "I have three more pairs of gloves that ripped today. All Sensicare PI".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934572 ↗MalfunctionSep 16, 2026Material Split, Cut or Torn
It was reported that "Glove tore at cuff while surgeon was doffing his gloves."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50793955 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
It was reported that they have 2 boxes of gloves that are splitting/torn in the middle.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50763405 ↗MalfunctionSep 13, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50747685 ↗MalfunctionAug 31, 2026Material Puncture/Hole
It was reported that they have 2 pairs of gloves with holes in them.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50525019 ↗
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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