MEDLINE MDSXB7585Recalls & reported problems
Medline Industries, Inc. · GLOVE,EXAM,PF,NITRILE,SILK,SMRTBX, M · Class 1
- Adverse event reports
- 24
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 30193489107764), received between Apr 13, 2026 and Sep 30, 2026 — classified as 24 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (24 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 Torn24
Patient problems
- No Clinical Signs, Symptoms or Conditions24
Recent adverse event reports
The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50954388 ↗MalfunctionSep 30, 2026Material Split, Cut or Torn
It was reported that Gloves tear easily.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945558 ↗MalfunctionSep 29, 2026Material Split, Cut or Torn
It was reported that "We are having numerous incidents where our clinicians are ripping through the gloves either while they are putting them on or in the middle of an exam."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50931623 ↗MalfunctionSep 18, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50828137 ↗MalfunctionSep 18, 2026Material Split, Cut or Torn
It was reported that Glove ripped.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50826323 ↗MalfunctionSep 11, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744652 ↗MalfunctionSep 11, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50744651 ↗MalfunctionSep 11, 2026Material Split, Cut or Torn
It was reported that, sensi-care gloves ripping when caregivers are attempting to use during patient care.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50725323 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50568062 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50565924 ↗MalfunctionSep 2, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50564981 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542486 ↗MalfunctionJul 17, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861394 ↗MalfunctionJul 17, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861337 ↗MalfunctionJul 17, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861151 ↗MalfunctionJul 17, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT THE GLOVES ARE "TEARING IN THE PALM."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861100 ↗MalfunctionJul 17, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25861042 ↗MalfunctionMay 8, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE GLOVES TEARING DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25128137 ↗MalfunctionMay 7, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE GLOVES RIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25116307 ↗MalfunctionMay 7, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE GLOVES RIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25114924 ↗MalfunctionMay 7, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE GLOVES RIPPING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25113590 ↗MalfunctionApr 13, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, SENSICARE SILK GLOVES TEARING AT THE CUFF WHEN TRYING TO PULL THEM DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24867502 ↗MalfunctionApr 13, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, SENSICARE SILK GLOVES TEARING AT THE CUFF WHEN TRYING TO PULL THEM DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866731 ↗MalfunctionApr 13, 2026Material Split, Cut or Torn
ACCORDING TO THE CUSTOMER, THE SENSICARE SILK GLOVES TEARING AT THE CUFF WHEN TRYING TO PULL THEM DOWN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24866289 ↗
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.