MEDLINE TRG400LRecalls & reported problems
Medline Industries, Inc. · GLOVE, EXAM, NITRILE, PF, LF, L · Class 1
- Adverse event reports
- 7
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00888277400576), received between May 14, 2026 and Sep 21, 2026 — classified as 2 injuries, 5 malfunctions.
The most frequently reported specific device problem is “Material Split, Cut or Torn” (5 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 Torn5
- Patient-Device Incompatibility2
Patient problems
- No Clinical Signs, Symptoms or Conditions5
- Skin Inflammation/ Irritation2
- Discomfort1
- Hypersensitivity/Allergic reaction1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846545 ↗MalfunctionSep 10, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50715224 ↗MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50697833 ↗MalfunctionSep 9, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50695090 ↗MalfunctionSep 7, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50650103 ↗InjuryMay 15, 2026Patient-Device Incompatibility
ACCORDING TO THE FACILITY, A TEAM MEMBER EXPERIENCED IRRITATION ON BOTH HANDS AFTER USING THE PRODUCT. CORTISONE CREAM WAS APPLIED. THE INDIVIDUAL SUBSEQUENTLY VISITED THE EMERGENCY ROOM AND RECEIVED STEROIDS FOR TREATMENT. THE INDIVIDUAL WAS REPORTED TO BE DOING BETTER AFTER BEING PROVIDED WITH SENSITIVE GLOVES.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 25184655 ↗InjuryMay 14, 2026Patient-Device Incompatibility
IT WAS REPORTED THAT, "THE TECHNOLOGIST HAS DEVELOPED VISIBLE RASHES ON BOTH HANDS AND BELIEVES THE IRRITATION MAY BE RELATED TO THE GLOVES CURRENTLY IN USE WITHIN OUR DEPARTMENT".
Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation
MAUDE report 25175850 ↗
Other Polymer patient examination glove devices
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- 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.