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ri-integral set Miller baby XL 2.5 V
Rudolf Riester GmbH · Model 8070 · UDI-DI 04045396008366
1
510(k) clearances
7,361
Adverse events (68 deaths)
53
Recalls
318
Facilities
Description
The laryngoscopes are manufactured in order to be used for endotracheal intubation. The Riester battery handles are used in order to supply the bulbs with energy and for fixation of the blades
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.