The Recall Desk
HighFDA (Devices)·Z-3308-2018·Announced 2018-10-10

Olympus Bronchovideoscope BF-XT160 Recalled for Instrument Channel Port Loosening

Olympus is recalling 861 Bronchovideoscope BF-XT160 units because using non-Olympus accessories may have caused the instrument channel port to loosen.

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: The recall involves a structural defect in a medical device that could lead to equipment failure during use, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 861 units of the Bronchovideoscope BF-XT160. The recall covers all lot codes and includes products distributed in the United States and Canada.

The recall was initiated because the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may have resulted in more applied force than expected. This excessive force could lead to the loosening of the instrument channel port.

Healthcare facilities and users should stop using the affected bronchoscopes and contact Olympus Corporation of the Americas for instructions on how to proceed.

The recalled product

Product
Bronchovideoscope BF-XT160
Affected units
861

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 lot codes

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 30 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.

See all 30 products in this recall →