Olympus BF-1T180 Bronchovideoscope Reprocessing Instructions Updated
Olympus Corporation is issuing updated reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope to comply with FDA 2015 guidance on medical device reprocessing validation.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving procedural updates to reprocessing instructions, with no reported illnesses, injuries, or deaths. The update appears to be compliance-driven—aligning with FDA 2015 guidance on validation—rather than responsive to confirmed patient harm.
Plain-English summary
Olympus Corporation of the Americas is updating the reprocessing instructions for the BF-1T180 EVIS EXERA II Bronchovideoscope, a medical device used in diagnostic and therapeutic procedures. The updated instructions are being issued according to FDA 2015 guidance on the validation of reprocessing methods for medical devices used in healthcare settings.
Approximately 1,694 units of this bronchovideoscope have been distributed domestically across the United States and additional units globally. These devices are used by healthcare facilities and medical professionals performing bronchial visualization and related procedures.
Healthcare providers and facilities currently using this device should obtain and implement the new validated reprocessing instructions. The updated instructions provide guidance on proper validation methods and labeling requirements for cleaning and sterilizing the device between patient uses.
The recalled product
- Product
- BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Hazard
- Affected units
- 1,694
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 (1)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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