IntuBrite 1031.CRecalls & reported problems

Salter Labs · MILL 1 SINGLE USE DISPOSABLE LARYNGOSCOPE BLADE · Class 1

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 00607411964695), received between Oct 23, 2024 and Feb 28, 2025 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Device Handling 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

Device Handling Problem1
Material Integrity Problem1
Use of Device Problem1
Visual Prompts will not Clear1

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.

MalfunctionFeb 28, 2025Visual Prompts will not Clear; Material Integrity Problem; Visual Prompts will not Clear; Material Integrity Problem
THE INTUBRITE BLADE DID NOT ADEQUATELY LIFT THE TONGUE AND SOFT TISSUES TO PROVIDE ADEQUATE VISUALIZATION FOR INTUBATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21497891 ↗
MalfunctionOct 23, 2024Use of Device Problem; Device Handling Problem; Use of Device Problem; Device Handling Problem
BLADE IS TOO NARROW COMPARED TO THE TELEFLEX WHICH MAKES IT DIFFICULT TO HOLD TONGUE TO MAINTAIN AIRWAY FOR INTUBATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20518183 ↗

Device details

UDI-DI	`00607411964695`
Brand	IntuBrite
Model	1031.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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.