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Welch Allyn, Inc.

WELCH ALLYN, INC. · Model 901038 · UDI-DI 00732094141306

CCW Prescription

510(k) clearances

7,361

Adverse events (68 deaths)

Recalls

318

Facilities

Description

Welch Allyn MacIntosh 2.5 V Standard Laryngoscope Set; Lamp at Distal Tip; Stainless Steel, Blade Sizes #1 to #4 (Qty. 4), Medium C- Cell Power Handle, Small AA-Cell Power Handle, Hard Storage Case

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	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	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.

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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.