Bronchovideoscope Reprocessing Instructions Updated Due to Sterilization Concerns
Olympus is issuing updated instructions for reprocessing its EVIS EXERA bronchovideoscopes to ensure proper sterilization and disinfection procedures. Improper reprocessing could compromise device safety.
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 a Class II medical device recall involving inadequate reprocessing instructions that directly affect sterilization safety. Although no illnesses or injuries have been reported, improper sterilization of a device used in invasive respiratory procedures constitutes a risk-of-harm scenario.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-3C160 EVIS EXERA bronchovideoscope due to concerns regarding reprocessing procedures. A total of 1,052 units with all serial numbers have been distributed nationwide throughout the United States.
The company has issued updated instructions for reprocessing the device. These instructions address the proper use of certain chemicals for reprocessing, conditions for ethylene oxide (ETO) gas sterilization, rinsing steps after high-level disinfection, and recommendations for sterilization. The updates are necessary to ensure that healthcare facilities properly sterilize and disinfect the device between uses on different patients.
Healthcare facilities currently using the EVIS EXERA bronchovideoscope should contact Olympus to obtain the updated reprocessing instructions and implement the revised procedures immediately.
The recalled product
- Product
- BF-3C160: EVIS EXERA Bronchovideoscope
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 1,052
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. UDI: 04953170340031
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 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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