Medline MSG9985Recalls & reported problems
Medline Industries, Inc. · SURG GL, SENSICARE PI ORTHO LT,LF,PF,8.5 · 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 10193489029888), received between Aug 13, 2026 and Sep 18, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (3 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 Torn3
- Material Fragmentation1
- Tear, Rip or Hole in Device Packaging1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 18, 2026Material Split, Cut or Torn
It was reported that the gloves were "breaking quite regularly with minimal effort/force."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50819813 ↗MalfunctionSep 8, 2026Material Fragmentation; Material Split, Cut or Torn
It was reported that "The gloves are ripping consistently during use" and "After one of the cases today, the Dr. noticed the glove was torn and a piece was missing that they could not find."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50668304 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50547913 ↗MalfunctionAug 13, 2026Tear, Rip or Hole in Device Packaging
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50236960 ↗
Other Surgeon's gloves devices
- GAMMEX 20685275Ansell Healthcare Product · Surgeon'S Gloves2 recalls0 reports
- 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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