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Richard Wolf GmbH · Model 844622 · UDI-DI 04055207010235

CCW

510(k) clearances

7,361

Adverse events (68 deaths)

Recalls

318

Facilities

Description

OP-LARYNGOSCOPE WL 154MM by Steiner, outer dimension prox. 32x15mm, inner dimension dist. Ø 16mm, TL 184mm, outer light carrier and insufflation-suction tube, with universal handle for all support and mounting systems, reusable

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.