MEDLINE CS16MRecalls & reported problems
Medline Industries, Inc. · GLOVE,EXAM,NITRILE,PF,CSPRO,EXT CUFF, M · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00888277396398), received between Jun 16, 2026 and Sep 2, 2026 — classified as 6 malfunctions.
The most frequently reported specific device problem is “Material Puncture/Hole” (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. 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 Puncture/Hole5
- Material Split, Cut or Torn1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Exposure to Body Fluids2
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 2, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50573529 ↗MalfunctionSep 1, 2026Material Puncture/Hole
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50550746 ↗MalfunctionSep 1, 2026Material Split, Cut or Torn
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50542827 ↗MalfunctionAug 28, 2026Material Puncture/Hole
Patient problems: Exposure to Body Fluids
MAUDE report 50508384 ↗MalfunctionAug 28, 2026Material Puncture/Hole
Patient problems: Exposure to Body Fluids
MAUDE report 50508381 ↗MalfunctionJun 16, 2026Material Puncture/Hole
IT WAS REPORTED THAT THERE ARE "SERIOUS CONCERNS ABOUT...SPD GLOVES. HE REPORTED ADDITIONAL GLOVE BREAKDOWN, WATER IN GLOVES AND NOW AN EMPLOYEE HAS AN INFECTED FINGER THAT THEY ARE SENDING TO OC HEALTH."
Patient problems: Unspecified Infection
MAUDE report 25519233 ↗
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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