MEDLINE OAT6802Recalls & reported problems
Medline Industries, Inc. · GLOVE, NITRILE, RESTORE OATMEAL, M · Class 1
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00888277180430), received between Jul 17, 2026 and Sep 30, 2026 — classified as 5 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Material Split, Cut or Torn3
- Fluid/Blood Leak1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
- Exposure to Body Fluids1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Fluid/Blood Leak
When she would doff the glove, her fingers were covered in patient¿s blood- has happened 3 times now during the extractions even with changing gloves mid-procedure. No tears in the gloves where the blood was (finger pads and under nail once). Which seems to be a porosity issue vs. tearing (even though these gloves seem to rip frequently).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946517 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932878 ↗MalfunctionSep 28, 2026Material Split, Cut or Torn
It was reported that "They were in a code and had to change out their gloves multiple times because their finger tips were coming thru the end of the gloves and they were ripping with extended use during a code."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50913762 ↗MalfunctionSep 8, 2026Material Split, Cut or Torn
Patient problems: Exposure to Body Fluids
MAUDE report 50669717 ↗MalfunctionJul 17, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25855584 ↗
Other Polymer patient examination glove devices
- Good Works 72-50602Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- Halyard 47461O&M Halyard, Inc. · Polymer patient examination glove1 recall0 reports
- Bosma Enterprises 72-50903Bosma Enterprises · Polymer Patient Examination Glove1 recall0 reports
- 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.