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Millennium
Avalign Technologies, Inc. · Model 72-4013251 · UDI-DI 00190776399658
10
510(k) clearances
7,576
Adverse events (70 deaths)
53
Recalls
318
Facilities
Description
Lindholm Operating Laryngoscope, Adult Large, with light carrier, 6" (15 cm), nominal proximal 39 x 24mm, distal 18mm
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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Get your free API keyRead the docsData 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.