The Recall Desk
HighFDA (Devices)·Z-3283-2018·Announced 2018-10-10

Olympus Recalls Bronchovideoscope BF-160 Due to Instrument Channel Port Loosening

Olympus is recalling 3,948 Bronchovideoscope BF-160 units because attaching non-Olympus accessories may loosen the instrument channel port.

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 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 3,948 units of the Bronchovideoscope BF-160. 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, leading to the loosening of the instrument channel port.

The affected products were distributed nationwide in the United States and in Canada. The recall covers all lot codes for this specific device model.

Healthcare providers and consumers should stop using the affected Bronchovideoscope BF-160 units and contact Olympus Corporation of the Americas for instructions on how to return or replace the devices.

The recalled product

Product
Bronchovideoscope BF-160
Affected units
3,948

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 →