The Recall Desk
HighFDA (Devices)·Z-2497-2021·Announced 2021-09-29

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.

What this means for you

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
Hazard
  • tube-leak
  • infection-control-risk

Distribution

Distributed nationwide across the United States.

Related recalls

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