UltraTM Earloop Mask GCFCXURecalls & reported problems
Crosstex International, Inc. · Blue, 40/box · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10732224120086), received between Dec 17, 2020 and Dec 17, 2025 — classified as 2 injuries, 1 malfunction.
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
- Adverse Event Without Identified Device or Use Problem2
- Break1
Patient problems
- Itching Sensation2
- Rash2
- Choking1
- Local Reaction1
- Red Eye(s)1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISTRIBUTOR REPORTED THAT USER IS HAVING AN ALLERGIC REACTION TO EARLOOPS ON MASK, RASH AND ITCHINESS. HAS BEEN HAPPENING FOR 5 OR 6 MONTHS.
Patient problems: Itching Sensation; Rash
MAUDE report 23828537 ↗MalfunctionJul 21, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A CUSTOMER REPORTED THAT WHEN WEARING CROSSTEX ULTRA FACE MASKS, THEY EXPERIENCED EYE REDNESS AND SKIN BURNING UNDER THE MASK.
Patient problems: Itching Sensation; Local Reaction; Rash; Red Eye(s)
MAUDE report 12206979 ↗InjuryDec 17, 2020Break; Break
THE USER FACILITY REPORTED THAT EAR LOOPS ON THEIR ULTRA FLUID RESISTANT MASKS HAD BECOME UNATTACHED. IN ONE INSTANCE THE EAR LOOP WENT INTO AN EMPLOYEE'S MOUTH AND BECAME LODGED IN THE EMPLOYEE'S TRACHEA.
Patient problems: Choking
MAUDE report 11030081 ↗
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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