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Ambler Surgical

AMBLER SURGICAL CORP. · Model Holinger ''hour glass'' anterior commissure laryngoscope · UDI-DI 00190660206239

CCW Prescription

510(k) clearances

7,485

Adverse events (68 deaths)

Recalls

318

Facilities

Description

Holinger ''hour glass'' anterior commissure laryngoscope, adult, 171.0mm overall length, min I.D. 7.7mm, autoclavable, Olympus connection

Recalls

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