Medline NON27385Recalls & reported problems
Medline Industries, Inc. · MASK,FACE,WHITE,HYPOALLERGENIC,FILTER · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30080196713978), received between Jan 14, 2025 and Mar 30, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available1
- Patient Device Interaction Problem1
Patient problems
- Hypersensitivity/Allergic reaction1
- Rash1
- Skin Inflammation/ Irritation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMar 30, 2026Patient Device Interaction Problem
ACCORDING TO THE FACILITY CONTACT "STARTING IN THE MIDDLE OF JANUARY," "WE HAVE HAD EMPLOYEE COMPLAINING ABOUT THE SURGICAL MASK BREAKING THEIR FACE OUT WITH HOT BRIGHT RED RASH."
Patient problems: Rash; Skin Inflammation/ Irritation
MAUDE report 24718650 ↗InjuryJan 14, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
ACCORDING TO THE CUSTOMER, THE PRODUCT IS CAUSING "ALLERGIC REACTIONS SO BADLY WE ARE HAVING TO GIVE BENADRYL INJECTIONS."
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 21154228 ↗
Other Mask, surgical devices
- Halyard 47117O&M Halyard, Inc. · Mask, surgical1 recall12 reports
- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
- Henry Schein 5702448Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
- Medline NON27410Medline Industries, Inc. · Mask, surgical14 reports
- UltraTM Earloop Mask GCFCXSCrosstex International, Inc. · Mask, surgical8 reports
- UltraTM Sensitive FogFreeTM Earloop Mask w/ Secure FitTM GCFCXSSFCrosstex International, Inc. · 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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