Auris Health, Inc. is recalling approximately 1,477 MONARCH Bronchoscopes (Model MBR-000211-B) because the devices may have leaks that were not detected during manufacturing. This occurred because a subset of the products was tested using equipment that was operating outside of its expected calibration range. Affected devices are medical instruments used in surgeries and can be identified by specific serial numbers with expiration dates between late 2024 and late 2025.
A leak in a bronchoscope can result in a loss of suction or the inability to maintain air pressure during a medical procedure. This failure can cause surgical delays or prevent the effective treatment of a patient, potentially leading to medical complications.
1,477 total units affected.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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