Bronchofibervideoscope Sterilization and Disinfection Procedure Update Recall
Olympus is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope due to updated instructions required for proper sterilization and reprocessing procedures. Updated guidance for chemical reprocessing, ETO gas sterilization, and disinfection rinsing steps is necessary.
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 medical device used in patient care. While no illnesses or injuries are reported in the source, improper sterilization procedures could lead to patient infection. The recall addresses a risk-of-harm product where preventive corrective action was taken before harm occurred.
Plain-English summary
Olympus Corporation of the Americas is recalling 292 units of the BF-MP160F EVIS EXERA Bronchofibervideoscope. This flexible videoendoscope is used in medical procedures to visualize and assess airways.
The recall addresses the need for updated instructions regarding proper reprocessing and sterilization of this medical device. Updated guidance is being issued for the use of certain chemicals in reprocessing, conditions for ETO gas sterilization, rinsing steps following high-level disinfection, and sterilization recommendations.
All 292 units of the BF-MP160F with all serial numbers are affected, as indicated by UDI 04953170289064. The affected devices have been distributed nationwide in the United States.
The recalled product
- Product
- BF-MP160F: EVIS EXERA Bronchofibervideoscope
- Manufacturer
- Olympus Corporation of the Americas
- Affected units
- 292
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: 04953170289064
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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