IntuBrite 1023.C2015.CRecalls & reported problems

Salter Labs · MAC 3/MEDIUM SINGLE USE DISPOSABLE LARYNGOSCOPE SYSTEM · Class 1

All models of IntuBrite (13)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 2
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00607411967702), received between Apr 5, 2024 and Jun 14, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Electrical /Electronic Property 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

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

Most reported problems

Device problems

Electrical /Electronic Property Problem1
Mechanical Problem1
No Device Output1

Patient problems

No Clinical Signs, Symptoms or Conditions2

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

MalfunctionJun 14, 2024Mechanical Problem; Mechanical Problem
THE LIGHT COMES ON BUT IS VERY DIM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19542072 ↗
MalfunctionApr 5, 2024Electrical /Electronic Property Problem; No Device Output; Electrical /Electronic Property Problem; No Device Output
DURING INTUBATION OUR LIGHT FLICKERED AND/OR WOULD NOT TURN ON .
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19055617 ↗

Device details

UDI-DI	`00607411967702`
Brand	IntuBrite
Model	1023.C2015.C
Company	Salter Labs
Product code	CCW · Laryngoscope, Rigid
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	Jan 14, 2019

Device type (GMDN): Laryngoscope blade, single-use

The segment of a laryngoscope (i.e., rigid intubation type) intended to be inserted into the oral cavity to manipulate the tongue, preventing it from obstructing the oropharynx and enabling a clear view of the trachea for the insertion of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It is connected to the laryngoscope handle and illumination of the airway is provided by a small built-in light bulb or a fibreoptic light. This device may be curved or straight and of various designs and lengths; it may be hinged/interchanged with the handle. Some types are magnetic resonance imaging (MRI) compatible. This is a single-use device.

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All Laryngoscope, Rigid 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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