The Recall Desk
HighFDA (Devices)·Z-3296-2018·Announced 2018-10-10

Olympus Bronchovideoscope BF-P160 Recalled for Instrument Channel Port Loosening

Olympus is recalling 1,874 Bronchovideoscope BF-P160 units because using 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 medical device with a structural defect (loosening port) that poses a risk of harm during use, but the source text does not report any specific injuries or illnesses, 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 1,874 units of the Bronchovideoscope BF-P160. 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 can lead to the loosening of the instrument channel port.

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

Healthcare providers and consumers should stop using the affected Bronchovideoscope BF-P160 units and contact Olympus Corporation of the Americas for further instructions on the recall process.

The recalled product

Product
Bronchovideoscope BF-P160
Affected units
1,874

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 →