UltraTM Sensitive FogFreeTM Earloop Mask w/ Secure FitTM GCFCXSSFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10732224120062), received between Sep 7, 2018 and Apr 18, 2025 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 18, 2025Material Puncture/Hole; Material Puncture/Hole

  THE DISTRIBUTOR, (B)(4), REPORTED THAT THE METAL STRIP OVER THE NOSE COMES OFF. A STAFF MEMBER WAS STRUCK WITH THE METAL PIECE. STAFF MEMBER WENT TO OPTOMETRIST FOR SCRAPED SCLERA.

  Patient problems: Eye Injury

  MAUDE report 21867759 ↗
• MalfunctionNov 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT AN EMPLOYEE EXPERIENCED A RASH ON THEIR FACE AFTER WEARING AN ULTRA SENSITIVE EARLOOP MASK W/SECURE FIT MASK TECHNOLOGY. THE EMPLOYEE WAS PRESCRIBED ANTIBIOTICS.

  Patient problems: Rash

  MAUDE report 18190129 ↗
• MalfunctionJun 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT EMPLOYEES OBTAINED SCRATCHES ON THEIR FACES WHILE WEARING ULTRA SENSITIVE EARLOOP MASKS W/SECURE FIT MASK TECHNOLOGY. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Abrasion

  MAUDE report 17226103 ↗
• MalfunctionNov 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE USER FACILITY REPORTED THAT STAFF MEMBERS EXPERIENCED SKIN IRRITATION WHILE WEARING ULTRA SENSITIVE EARLOOP FACE MASKS. THE USER FACILITY DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 15820365 ↗
• InjurySep 7, 2018Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  A DENTAL OFFICE REPORTED THAT A HYGIENIST EXPERIENCED ALLERGIC REACTION SYMPTOMS, INCLUDING ANAPHYLAXIS, WHILE WEARING A CROSSTEX ULTRA SENSITIVE SECURE FIT FACE MASK FOR THE FIRST TIME.

  Patient problems: Anaphylactic Shock; Confusion/ Disorientation; Rash; Skin Irritation; Swelling

  MAUDE report 7855043 ↗