Bronchovideoscope Reprocessing Instructions Updated for Sterilization Compliance
Olympus Corporation is issuing updated reprocessing instructions for the BF-XP160F EVIS EXERA Bronchovideoscope according to FDA 2015 guidance. All serial numbers are affected.
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 3/5 (High).
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: This is an FDA Class II recall of a high-risk medical device used in respiratory procedures. Improper reprocessing could lead to serious infections; although no illnesses or injuries have been reported, the hazard of infection from inadequate sterilization represents a risk-of-harm scenario requiring the issuance of validated updated procedures.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-XP160F EVIS EXERA Bronchovideoscope to issue validated, new reprocessing instructions. The updated procedures align with the FDA 2015 guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
The recall affects all serial numbers of the BF-XP160F model. A total of 644 units have been distributed domestically nationwide and internationally.
Healthcare facilities using this bronchovideoscope should implement the new reprocessing instructions provided by Olympus. Proper reprocessing of endoscopic equipment is critical to prevent cross-contamination and potential patient harm from inadequate sterilization.
The recalled product
- Product
- BF-XP160F EVIS EXERA Bronchovideoscope, Model No. BF-XP160F
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 644
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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