[pending] MONARCH Bronchoscope. Model Number: MBR-000211-B
Pending LLM rewrite. Source: FDA_DEVICE Z-0543-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
The recalled product
- Product
- MONARCH Bronchoscope. Model Number: MBR-000211-B
- Manufacturer
- Auris Health, Inc
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 1311678 (11/14/2024)
- 1311679 (11/14/2024)
- 1311680 (11/14/2024)
- 1311681 (11/14/2024)
- 1311682 (11/14/2024)
- 1311683 (11/14/2024)
- 1311684 (11/14/2024)
- 1311685 (11/14/2024)
- 1311686 (11/14/2024)
- 1311687 (11/14/2024)
- 1311688 (11/14/2024)
- 1311722 (11/15/2024)
- 1311723 (11/15/2024)
- 1311724 (11/15/2024)
- 1311725 (11/15/2024)
- 1311726 (11/15/2024)
- 1311727 (11/15/2024)
- 1311730 (11/15/2024)
- 1311731 (11/15/2024)
- 2404220489 (11/21/2024)
Distribution
Distributed nationwide across the United States.
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