FDA Device Intelligence
Home › SONTEC INSTRUMENTS, INC. › Pashley Laryngoscope

Pashley Laryngoscope

SONTEC INSTRUMENTS, INC. · Model 1412-568 · UDI-DI 00192896122192

CCW Prescription
10
510(k) clearances
7,576
Adverse events (70 deaths)
53
Recalls
318
Facilities

Description

Pashley Laryngoscope Narrow End With Suction

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.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
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.