Medline NON27378Recalls & reported problems
Medline Industries, Inc. · MASK,FACE,BLUE,PROCEDURE,EARLOOP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10080196717996), received between Apr 15, 2026 and Sep 29, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Break” (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. 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
- Break2
- Detachment of Device or Device Component1
- Material Split, Cut or Torn1
Patient problems
- Insufficient Information2
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936650 ↗MalfunctionJun 1, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT CUSTOMER TRIED ON AT LEAST 10 MASKS AND THE EAR LOOPS JUST FALL OFF; THE ITEMS ARE DEFECTIVE.
Patient problems: Insufficient Information
MAUDE report 25355880 ↗MalfunctionMay 7, 2026Break
PER EMAIL, CUSTOMER EXPLAINED THAT ONE EAR LOOP WOULD SNAP WHEN PUTTING ON.
Patient problems: Insufficient Information
MAUDE report 25118731 ↗MalfunctionApr 15, 2026Break
CUSTOMER REPORTED, "THE BAND BREAKS RIGHT OFF WITH JUST A SMALL PULL-ON MASK. I HAD A DOCTOR GO THROUGH 3 BEFORE HE GAVE UP AND INSTEAD USED ANOTHER MASK AS SOON AS HE WOULD PULL BAND TO GO AROUND EAR IT WOULD JUST BREAK RIGHT OFF."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24886829 ↗
Other Mask, surgical devices
- Halyard 47117O&M Halyard, Inc. · Mask, surgical1 recall12 reports
- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Henry Schein 5702448Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Medline NON27410Medline Industries, Inc. · Mask, surgical14 reports
- UltraTM Earloop Mask GCFCXSCrosstex International, Inc. · Mask, surgical8 reports
- CONVERTORS AT70021Cardinal Health 200, LLC · Mask, surgical5 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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