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LARYNGOSCOPE

ENTER MEDICAL CORPORATION · Model ENT-2002 · UDI-DI 04719872102007

CCW Prescription
10
510(k) clearances
7,361
Adverse events (68 deaths)
53
Recalls
318
Facilities

Description

A hand-held disposable device intended to be used by anaesthesia/emergency service personnel 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.

Recalls

DateFirmReason
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-07-11Flexicare Medical (Dongguan) Ltd.Laryngoscope handles may not illuminate as intended.
2025-06-17Intersurgical IncPotential for faulty devices as a result of depleted batteries.
2024-07-09CovidienBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.
2024-07-09CovidienIFU update to address device's battery handling information.
2024-07-09CovidienBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of explosion.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.