Bronchofibervideoscope recalled for potential leak in insertion tube
Olympus is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope due to a missing gluing step in manufacturing. The affected devices may develop leaks in the insertion tube, posing an infection control risk.
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: FDA Class II medical device recall with no reported illnesses or injuries. The hazard is theoretical—a potential for tube leakage that creates infection control risk—without documented harm to patients, placing it in the 'High' category for risk-of-harm products.
Plain-English summary
Olympus Corporation of the Americas is recalling the EVIS EXERA BF-XT160 bronchofibervideoscope. A manufacturing defect in the affected devices involved a missing gluing step during production of the insertion tube.
The missing gluing step creates a potential for the insertion tube to develop a leak. A leak in the insertion tube poses an infection control risk during clinical use.
The recall affects 21 devices distributed in the United States across California, Illinois, Massachusetts, Maryland, Michigan, New York, Ohio, Oregon, and Pennsylvania. Approximately 27 devices are affected globally. Healthcare facilities that have received one of the affected devices should immediately discontinue use and contact Olympus Corporation of the Americas.
The recalled product
- Product
- EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
Distribution
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