FitGuard FG2504Recalls & reported problems
Medline Industries, Inc. · GLOVE,EXAM,NITRL,PF,TXT FNGR,XL · Class 1
- 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 00080196170923), received between May 17, 2026 and Sep 30, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (2 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 Torn2
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 30, 2026Material Split, Cut or Torn
It was reported that "the new purple Fit Guard gloves are falling apart or ripping while putting them on" and "these gloves have failed during patient care."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951695 ↗MalfunctionMay 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT, CLINICAL TEAM HAS COMPLAINED THAT 1 OUT OF 4 XL GLOVES ARE RIPPING DOWN THE MIDDLE WHEN THE CLINICIAN PUTS THEM ON. THIS IS CAUSING A RISK OF BLOOD BORNE PATHOGEN CONTAMINATION. GLOVES WERE TOSSED AND NEW ONE WAS TRIED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25196106 ↗
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- Bosma Enterprises 72-50902Bosma Enterprises · 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 47460O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50900Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.