Halyard 48207Recalls & reported problems

O&M Halyard, Inc. · HYH,SRGCL,MASK,OR,-,300 · 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 20680651482079), received between Mar 17, 2025 and Mar 17, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination” (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.

Reports received per month

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

Most reported problems

Device problems

Contamination1
Material Integrity Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

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

MalfunctionMar 17, 2025Contamination; Material Integrity Problem; Contamination; Material Integrity Problem
A PHYSICIAN HAD DEBRIS FALL FROM THEIR MASK ONTO STERILE FIELD. THE STERILE FIELD HAD TO BE DRAPED AGAIN. THERE WAS NO PATIENT HARM AS A RESULT OF THIS INCIDENT. THIS INCIDENT OCCURRED PRIOR TO USE WITH A PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21619361 ↗

Device details

UDI-DI	`20680651482079`
Brand	Halyard
Model	48207
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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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.

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