Criterion 5703276Recalls & reported problems

Henry Schein, Inc. · Ultrasoft Earloop Mask L3, Blue · Class 2

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040168950), received between Jan 14, 2026 and Jan 14, 2026 — classified as 1 injury.

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1

Patient problems

Skin Discoloration1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
A NURSE EXPERIENCED TEMPORARY REDNESS ON THE NOSE AFTER WEARING THE MASK WITH THE BLUE SIDE FACING OUTWARD. THE NURSE HAD USED THIS MASK TYPE BEFORE INSIDE OUT WITHOUT ISSUES, REPORTED NO KNOWN ALLERGIES, NO BROKEN SKIN AND REQUIRED NO MEDICAL TREATMENT OR FOLLOW-UP.
Patient problems: Skin Discoloration
MAUDE report 24072255 ↗

Device details

UDI-DI	`00304040168950`
Brand	Criterion
Model	5703276
Company	Henry Schein, Inc.
Product code	FXX · Mask, surgical
Class	Class 2
FDA submission	K103303
Implant	No
Rx / OTC	OTC
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Dec 5, 2023

Device type (GMDN): Surgical/medical respirator, non-antimicrobial, single-use

A form-shaped filtering mask designed to be placed over the nose and mouth of a healthcare worker to permit normal breathing while protecting the wearer and patient from large particles (e.g., body fluids, airborne particulate materials) and small particles (e.g., bacteria) during medical, surgical, dental, and isolation procedures; it does not include an antimicrobial agent(s). It is designed to create an airtight seal against the user’s face, and typically includes ties/head straps; it might incorporate a forming nosepiece (metal wire) and/or an exhalation valve. This is a single-use device.

Other Mask, surgical devices

Halyard 47117
O&M Halyard, Inc. · Mask, surgical
1 recall12 reports
Halyard 47147
O&M Halyard, Inc. · Mask, surgical
1 recall1 report
Halyard 47500
O&M Halyard, Inc. · Mask, surgical
1 recall0 reports
Henry Schein 5702448
Henry Schein, Inc. · Mask, surgical
1 recall0 reports
Criterion 5703281
Henry Schein, Inc. · Mask, surgical
1 recall0 reports
Medline NON27410
Medline Industries, Inc. · Mask, surgical
14 reports
UltraTM Earloop Mask GCFCXS
Crosstex International, Inc. · Mask, surgical
8 reports
CONVERTORS AT70021
Cardinal Health 200, LLC · Mask, surgical
5 reports

All Mask, surgical devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.