Is BF-MP60: OES Bronchofiberscope recalled?

Medium RiskFDA Device

Olympus Corporation of the Americas: Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization

Agency Publication Date: May 6, 2022

Affected Products

Product: BF-MP60: OES Bronchofiberscope

All serial numbers. UDI: 04953170339394

Product: BF-3C160: EVIS EXERA Bronchovideoscope

All serial numbers. UDI: 04953170340031

Product: BF-MP160F: EVIS EXERA Bronchofibervideoscope

All serial numbers. UDI: 04953170289064

Product: BF-1TQ180: EVIS EXERA II Bronchovideoscope

All serial numbers. UDI: 04953170339349

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89942

Status: Active

Manufacturer: Olympus Corporation of the Americas

Manufactured In: United States

Units Affected: 4 products (60 units; 1052 units; 292 units; 242 units)

Were You Affected by This Recall?

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.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.