n/a SO-298-0Recalls & reported problems

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

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 00607411902970), received between Feb 6, 2026 and Feb 6, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Inflation 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

Inflation 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.

MalfunctionFeb 6, 2026Inflation Problem
IT WAS REPORTED THAT THE RESERVOIR BAG DID NOT INFLATE PROPERLY DURING USE ON A PATIENT. THERE WAS NO REPORT OF ANY DELAY IN THERAPY, HARM, OR INJURY AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24284792 ↗

Device details

UDI-DI	`00607411902970`
Brand	n/a
Model	SO-298-0
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

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Salter Labs · MASK, OXYGEN, NON-REBREATHING
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1 report
AirLife™ 001203
Vyaire Medical, Inc. · MASK, OXYGEN, NON-REBREATHING
1 report
HUDSON RCI HUD1936
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1 report
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Salter Labs · MASK, OXYGEN, NON-REBREATHING
1 report

All MASK, OXYGEN, NON-REBREATHING 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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