UltraTM Earloop Mask GCFCXSRecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10732224120017), received between Dec 10, 2019 and Feb 11, 2026 — classified as 6 injuries, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  DISTRIBUTOR REPORTS THAT CUSTOMER STATED THE MASK CAUSED SKIN IRRITATION AND HAD A ROUGHER TEXTURE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 24314022 ↗
• InjuryDec 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CUSTOMER REPORTED THAT THEIR FACE WAS RED, HOT, AND HAD BUMPS, ALONG WITH THEIR EYES AND TONGUE TINGLING AND BURNING WHILE WEARING THE MASK. ONCE REMOVED, THE SYMPTOMS STOPPED WITHIN 30 MINUTES.

  Patient problems: Rash; Skin Burning Sensation

  MAUDE report 23822030 ↗
• InjuryNov 26, 2024Material Puncture/Hole; Material Puncture/Hole

  WHILE USING THE MASK THE WIRE CAME OUT AND IT SCARTCHED THE DOCTOR EYE.

  Patient problems: Eye Injury; Eye Pain

  MAUDE report 20789560 ↗
• MalfunctionMar 15, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED THAT EMPLOYEES ARE EXPERIENCING "BREAK OUTS AND ITCHING" FROM THEIR ULTRA FLUID EARLOOP MASKS. IT IS UNKNOWN IF EMPLOYEES SOUGHT OR RECEIVED MEDICAL TREATMENT.

  Patient problems: Itching Sensation

  MAUDE report 18917689 ↗
• MalfunctionJul 1, 2022Adverse 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 WITHIN 3 WEEKS OF USING THE ULTRA SENSITIVE EARLOOP MASK AN EMPLOYEE'S FACE WAS BURNING AND HAD BLISTERS. THE EMPLOYEE WAS TREATED WITH PREDNISONE.

  Patient problems: Blister

  MAUDE report 14885063 ↗
• InjuryMar 19, 2020Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Patient-Device Incompatibility; Adverse Event Without Identified Device or Use Problem

  CROSSTEX RECEIVED A REPORT THROUGH DISTRIBUTOR (B)(4) DENTAL, THAT A DENTIST AND DENTAL ASSISTANT EXPERIENCED EXPOSURE SYMPTOMS AFTER WEARING THE CROSSTEX ULTRA FLUID RESISTANT MASK.

  Patient problems: Irritation; Rash; Reaction

  MAUDE report 9853460 ↗
• InjuryMar 3, 2020Patient-Device Incompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Patient Device Interaction Problem

  CROSSTEX RECEIVED A REPORT THROUGH A DISTRIBUTOR, (B)(6), THAT A PHYSICIAN EXPERIENCED A RASH AFTER WEARING THE CROSSTEX ULTRA SENSITIVE EARLOOP MASK.

  Patient problems: Rash

  MAUDE report 9779651 ↗
• InjuryDec 10, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CROSSTEX RECEIVED A REPORT THROUGH A DISTRIBUTOR, HENRY SCHEIN, THAT ONE OF THEIR CUSTOMERS EMPLOYEES EXPERIENCED ITCHINESS AND REDNESS AFTER WEARING THE CROSSTEX ULTRA SENSITIVE EARLOOP MASK.

  Patient problems: Itching Sensation; Local Reaction; Rash

  MAUDE report 9445723 ↗