n/a SO-430-0Recalls & reported problems

Salter Labs · Oxygen Mask (Adult) High concentration non-rebreather, with safety vent 7' (2.1m) supply tube Elastic strap fixation. · Class 1

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 00607411800849), received between Nov 22, 2023 and Nov 22, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Connection 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. 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

Connection Problem1

Patient problems

Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1

Recent adverse event reports

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

MalfunctionNov 22, 2023Connection Problem; Connection Problem
THE RESERVOIR BAG DISCONNECTED FROM THE MASK.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 18196863 ↗

Device details

UDI-DI	`00607411800849`
Brand	n/a
Model	SO-430-0
Company	Salter Labs
Product code	KGB · MASK, OXYGEN, NON-REBREATHING
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	No
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Jan 27, 2026

Device type (GMDN): Non-rebreathing oxygen face mask

A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.

Other MASK, OXYGEN, NON-REBREATHING devices

HUDSON RCI HUD1060
Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING
5 reports
HUDSON RCI HUD1059
Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING
3 reports
n/a 8130-7
Salter Labs · MASK, OXYGEN, NON-REBREATHING
2 reports
AirLife™ 001203
Vyaire Medical, Inc. · MASK, OXYGEN, NON-REBREATHING
1 report
HUDSON RCI HUD1936
Medline Industries, Inc. · MASK, OXYGEN, NON-REBREATHING
1 report
n/a 8140-7
Salter Labs · MASK, OXYGEN, NON-REBREATHING
1 report
n/a SO-298-0
Salter Labs · MASK, OXYGEN, NON-REBREATHING
1 report

All MASK, OXYGEN, NON-REBREATHING devices →

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