Precept® 15301Recalls & reported problems

Precept Medical Products, Inc. · FLUIDGARD® 160 ANTI-FOG PROCEDURE MASK · 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 10814707020219), received between Sep 2, 2026 and Sep 2, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Patient-Device Incompatibility” (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

Patient-Device Incompatibility1

Patient problems

Asthma1

Recent adverse event reports

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

MalfunctionSep 2, 2026Patient-Device Incompatibility
Patient problems: Asthma
MAUDE report 50568545 ↗

Device details

UDI-DI	`10814707020219`
Brand	Precept®
Model	15301
Company	Precept Medical Products, Inc.
Product code	FXX · Mask, Surgical
Class	Class 2
FDA submission	K771409
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	May 6, 2020

Device type (GMDN): Surgical/medical face mask, 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) during medical procedures and patient examination; 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 intended to protect the upper face/eyes from debris/fluid. 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 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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