Halyard 28802Recalls & reported problems

O&M Halyard, Inc. · HYH,SRGCL,MASK,BU,-,50 · Class 2

Data updated Oct 16, 2026 from official FDA records · Editorial policy

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 20680651288022), received between Feb 6, 2019 and Feb 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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 16, 2026.

Most reported problems

Device problems

Patient Device Interaction Problem1

Patient problems

Inflammation1
Reaction1

Recent adverse event reports

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

InjuryFeb 6, 2019Patient Device Interaction Problem; Patient Device Interaction Problem
IT WAS REPORTED THAT FOLLOWING THE USE OF A MASK, A DOCTOR HAD AN ALLERGIC REACTION. THE DOCTOR DEVELOPED SWOLLEN LIPS AND TONGUE AND NEEDED TREATMENT, WHICH INCLUDED STEROID INJECTION. THE DOCTOR WAS INFORMED HIS SYMPTOMS WERE DUE TO AN ALLERGIC RESPONSE. ADDITIONAL INFORMATION WAS RECEIVED ON 15-JAN-2019 FROM THE DOCTOR THAT STATED, ALL OK. NO ADDITIONAL INFORMATION WAS PROVIDED.
Patient problems: Inflammation; Reaction
MAUDE report 8311908 ↗

Device details

UDI-DI	`20680651288022`
Brand	Halyard
Model	28802
Company	O&M Halyard, 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	Aug 30, 2023

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

A flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials). It does not include an antimicrobial/antiviral agent(s) and it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor. This is a single-use device.

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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 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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