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Millennium
Avalign Technologies, Inc. · Model 72-402030 · UDI-DI 00190776396039
10
510(k) clearances
7,576
Adverse events (70 deaths)
53
Recalls
317
Facilities
Description
Holinger "Hour Glass" Anterior Commissure Laryngoscope, adult, 171mm length, with light carrier, 7.7mm min I.D., 12x20mm nominal proximal I.D.
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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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.