Ultra Surgical Masks GCFCXUSFRecalls & reported problems
Crosstex International, Inc. · With Secure Fit Technology, ASTM Level 3, Blue · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10732224120093), received between May 11, 2023 and Jun 15, 2023 — classified as 2 malfunctions.
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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Skin Inflammation/ Irritation2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT A STUDENT AND INSTRUCTOR EXPERIENCED RASHES AND SKIN IRRITATION WHILE WEARING ULTRA EARLOOP MASKS W/SECURE FIT MASK TECHNOLOGY. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17137336 ↗MalfunctionMay 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE USER FACILITY REPORTED THAT EMPLOYEES EXPERIENCED SKIN IRRITATION WHILE WEARING ULTRA EARLOOP MASKS W/SECURE FIT MASK TECHNOLOGY. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 16914633 ↗
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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