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FitGuard FG2502Recalls & reported problems

Medline Industries, Inc. · GLOVE,EXAM,NITRL,PF,TXT FNGR,M · Class 1

Adverse event reports
10
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00884389170918), received between Jun 12, 2026 and Sep 29, 2026 — classified as 10 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

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 2 reportsJul 2026: 0 reportsAug 2026: 1 reportsSep 2026: 7 reportsOct 2026: 0 reports2024202520267
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Material Split, Cut or Torn7
  • Material Puncture/Hole2
  • Inadequacy of Device Shape and/or Size1

Patient problems

  • No Clinical Signs, Symptoms or Conditions10

Recent adverse event reports

The 10 most recent of 10 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 50937569 ↗
  • MalfunctionSep 29, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50933649 ↗
  • MalfunctionSep 9, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50700127 ↗
  • MalfunctionSep 2, 2026Material Split, Cut or Torn

    It was reported that "An employee was cleaning glassware and the glove ripped in half down the palm."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50566147 ↗
  • MalfunctionSep 1, 2026Material Puncture/Hole

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50545262 ↗
  • MalfunctionSep 1, 2026Inadequacy of Device Shape and/or Size

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50544597 ↗
  • MalfunctionSep 1, 2026Material Puncture/Hole

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50543816 ↗
  • MalfunctionAug 31, 2026Material Split, Cut or Torn

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 50526417 ↗
  • MalfunctionJun 17, 2026Material Split, Cut or Torn

    IT WAS REPORTED "I NOTICED OUR CLEAN GLOVES ARE VERY BRITTLE. THEY TEAR VERY EASILY."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25536729 ↗
  • MalfunctionJun 12, 2026Material Split, Cut or Torn

    IT WAS REPORTED THAT THE "ONE OF OUR PA'S OPENED A NEW BOX AND EVERY TIME HE PUT A NEW GLOVE ON THE FINGERS WOULD TEAR OUT, SO HE OPENED ANOTHER NEW BOX AND THE SAME THING HAPPENED."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25492159 ↗

Other Polymer patient examination glove devices

All Polymer patient examination glove devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.