Medline NON27122Recalls & reported problems
Medline Industries, Inc. · MASK,FACE,YELLOW,ISOLATION,EARLOOP · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10080196717972), received between Jan 31, 2023 and Sep 21, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Appropriate Device Problem Term/Code Not Available1
- Break1
- Detachment of Device or Device Component1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Detachment of Device or Device Component
It was reported that the straps of the facemasks were detaching when removing them from the box.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50846231 ↗MalfunctionJun 3, 2026Break
IT WAS REPORTED THAT THE TOP RIGHT ELASTIC BAND COMES OFF.
Patient problems: Insufficient Information
MAUDE report 25385567 ↗InjuryJan 31, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE FACILITY "ONE STAFF MEMBER HAD TO BE TREATED FOR A SEVERE BREAKOUT IN RELATION TO THE USE OF THE MASK".
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16271629 ↗
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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