UltraTM FogFreeTM Earloop Mask GCFCXRecalls & reported problems
Crosstex International, Inc. · Blue, 40/box · Class 2
Data updated Oct 18, 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 10732224120000), received between Apr 20, 2023 and Sep 30, 2026 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 18, 2026.
Reports received per month
Most reported problems
Device problems
- Insufficient Device Problem Information2
- Adverse Event Without Identified Device or Use Problem1
- Material Fragmentation1
- Material Integrity Problem1
Patient problems
- Aspiration/Inhalation1
- Cough1
- Rash1
- Skin Inflammation/ Irritation1
- Vomiting1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 30, 2026Material Fragmentation
Patient problems: Aspiration/Inhalation; Cough; Vomiting
MAUDE report 50952850 ↗MalfunctionAug 11, 2023Material Integrity Problem; Insufficient Device Problem Information; Material Integrity Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT STAFF MEMBERS EXPERIENCED SKIN IRRITATION WHILE WEARING ULTRA FOGFREE EARLOOP MASKS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17509026 ↗MalfunctionApr 20, 2023Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information; Adverse Event Without Identified Device or Use Problem; Insufficient Device Problem Information
THE USER FACILITY REPORTED THAT TWO EMPLOYEES EXPERIENCED A RASH ON THEIR FACE WHILE WEARING ULTRA FOGFREE EARLOOP MASKS. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Rash
MAUDE report 16781568 ↗
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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