MEDLINE MSG9065Recalls & reported problems
Medline Industries, Inc. · GLOVE,SURG,SENSICARE PI,LF,PF,6.5 · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 12
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10888277347885), received between Aug 31, 2026 and Sep 29, 2026 — classified as 12 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (9 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 Torn9
- Material Puncture/Hole2
- Contamination1
- Degraded1
- Device Contamination with Chemical or Other Material1
Patient problems
- No Clinical Signs, Symptoms or Conditions12
Recent adverse event reports
The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50937622 ↗MalfunctionSep 28, 2026Material Puncture/Hole; Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923815 ↗MalfunctionSep 28, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50923814 ↗MalfunctionSep 25, 2026Degraded; Device Contamination with Chemical or Other Material
It was reported that "Sensicare gloves for having ink on them, or transfer of the LOT Stamp on the top of the glove to the bottom of the glove (palm). I have also been getting complaints of the same gloves being stiff and breaking apart."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900314 ↗MalfunctionSep 21, 2026Contamination
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846726 ↗MalfunctionSep 21, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50840426 ↗MalfunctionSep 19, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50831859 ↗MalfunctionSep 14, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50765038 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50575682 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573812 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50541102 ↗MalfunctionAug 31, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50532158 ↗
Other Surgeon's gloves devices
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- 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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