Henry Schein 1047799Recalls & reported problems

Henry Schein, Inc. · Earloop Mask Procedural · Class 2

Data updated Oct 13, 2026 from official FDA records · Editorial policy

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

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00304040005200), received between Jun 7, 2023 and Jun 7, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

Adverse Event Without Identified Device or Use Problem1
Insufficient Device Problem Information1

Patient problems

Skin Inflammation/ Irritation1

Recent adverse event reports

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

MalfunctionJun 7, 2023Adverse 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 EMPLOYEES AND PATIENTS EXPERIENCED RASHES AND SKIN IRRITATION WHILE WEARING PROCEDURE MASKS ASTM LEVEL 2 BLUE ADULT. NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.
Patient problems: Skin Inflammation/ Irritation
MAUDE report 17079250 ↗

Device details

UDI-DI	`00304040005200`
Brand	Henry Schein
Model	1047799
Company	Henry Schein, Inc.
Product code	FXX · Mask, surgical
Class	Class 2
FDA submission	None listed
Implant	No
Rx / OTC	—
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Sep 13, 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 and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page