HUDSON RCI HUD1936Recalls & reported problems

Medline Industries, Inc. · MASK,OXY,NONREBREATHING,ADLT,7',UC · Class 1

All models of HUDSON RCI (30)

Data updated Oct 18, 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 10197344009602), received between Aug 18, 2026 and Aug 18, 2026 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (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 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Material Rupture1

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.

MalfunctionAug 18, 2026Material Rupture
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50303888 ↗

Device details

UDI-DI	`10197344009602`
Brand	HUDSON RCI
Model	HUD1936
Company	Medline Industries, Inc.
Product code	KGB · MASK, OXYGEN, NON-REBREATHING
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	No
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	Nov 24, 2025

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
n/a SO-298-0
Salter Labs · MASK, OXYGEN, NON-REBREATHING
1 report
n/a SO-430-0
Salter Labs · MASK, OXYGEN, NON-REBREATHING
1 report
n/a 8140-7
Salter Labs · MASK, OXYGEN, NON-REBREATHING
1 report
AirLife™ 001203
Vyaire Medical, Inc. · 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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

How reports and recalls are matched · Editorial policy · Report an error on this page