FitGuard FG2503Recalls & reported problems
Medline Industries, Inc. · GLOVE,EXAM,NITRL,PF,TXT FNGR,L · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00888277170912), received between Aug 7, 2026 and Sep 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Integrity Problem” (1 report).
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 Integrity Problem1
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Material Split, Cut or Torn
It was reported that "the new purple Fit Guard gloves are falling apart or ripping while putting them on. They haven't even started their procedure yet." It was also reported that "They have also failed during procedure with our \"dirty\" scopes, so bare hands are now touching the scopes.".
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933871 ↗MalfunctionAug 7, 2026Material Integrity Problem
It was reported that the gloves were tearing.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50175188 ↗
Other Polymer patient examination glove devices
- Halyard 48774O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 48773O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50803Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 48771O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Good Works 72-50602Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 47461O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Halyard 47462O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50903Bosma Enterprises · Polymer Patient Examination Glove1 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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