McGRATH MAC 350-084-000Recalls & reported problems

Covidien LP · Disposable Laryngoscope Blade 2 · Class 1

All models of McGRATH MAC (11)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

Aug 10, 2023Class IIOpen, Classified
Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.
Z-0169-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Device details

UDI-DI	`10884521824386`
Brand	McGRATH MAC
Model	350-084-000
Company	Covidien LP
Product code	CCW · LARYNGOSCOPE, RIGID
Class	Class 1
FDA submission	None listed
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 18, 2026

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.

Other LARYNGOSCOPE, RIGID devices

McGRATH MAC 301-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 recalls202 reports
McGRATH MAC 300-000-000
Covidien LP · LARYNGOSCOPE, RIGID
1 recall1 death205 reports
n.a. 8404HX
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
242 reports
McGRATH 340-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 deaths192 reports
McGRATH MAC 301-000-000
Covidien LP · LARYNGOSCOPE, RIGID
2 recalls90 reports
n.a. 8404BXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
141 reports
n/a 8404AXC
Karl Storz GmbH & Co. KG · LARYNGOSCOPE, RIGID
108 reports
McGRATH 340-000-000
Covidien LP · LARYNGOSCOPE, RIGID
84 reports

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
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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