Auris Health recalls Monarch Bronchoscope model MBR-000211-B due to potential leak testing issues that may cause improper leak resistance. Affected units have specific serial numbers with expiration dates through November 2024. Consumers should check their serial numbers and contact Auris Health for details.
Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Auris Health is recalling Monarch Bronchoscope model MBR-000211-B because some units may not be properly leak-tested, potentially leading to leaks during use. This could cause issues during medical procedures. Affected units have specific serial numbers with expiration dates through November 2024.
The bronchoscope may not have been properly leak-tested during manufacturing, which could result in leaks during medical procedures. This is a potential issue with the product's integrity but does not pose an immediate risk of injury or serious harm.
Healthcare professionals who own or use the Monarch Bronchoscope model MBR-000211-B with the listed serial numbers are affected. The risk is low as the issue relates to potential leak testing rather than immediate safety hazards.
Check if your Monarch Bronchoscope has the model number MBR-000211-B and the listed serial numbers with expiration dates through November 2024. The serial numbers are provided in the recall notice with specific expiration dates.
Look for the serial number on your Monarch Bronchoscope. If it matches the list of affected serial numbers with expiration dates through November 2024, it is part of the recall.
The recalled model number is MBR-000211-B.
Check the serial number on your Monarch Bronchoscope. If it matches the list of affected serial numbers with expiration dates through November 2024, it is part of the recall.
Contact Auris Health directly to confirm if your unit is affected and follow their instructions for next steps.
We’ve drafted a message you can send Auris Health to request your refund or repair — edit it as you like.
Subject: Recall Z-0543-2026 — Auris Health Auris Health Hello, I own a Auris Health that is covered by recall Z-0543-2026 from Auris Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
