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Curaplex
BOUND TREE MEDICAL, LLC · Model B1100 · UDI-DI 00810071636554
CCW
Prescription
10
510(k) clearances
7,361
Adverse events (68 deaths)
53
Recalls
318
Facilities
Description
Curaplex Laryngoscope blade, Miller, sz 00, premature, 65 mm, American profile, SS, frosted lamp
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.