The Recall Desk
HighFDA (Devices)·Z-3300-2018·Announced 2018-10-10

Olympus Bronchofiberscope BF-P60 Recalled Due to Instrument Channel Port Loosening

Olympus is recalling 5,545 Bronchofiberscope BF-P60 units because attaching non-Olympus accessories may cause 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 medical device with a structural defect that could lead to equipment failure during use, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 5,545 units of the Bronchofiberscope BF-P60. The recall is due to a potential defect where the attachment of non-Olympus accessories to the bronchoscope's instrument channel port may result in more applied force than expected. This increased 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 covers all lot codes for this specific model.

Healthcare providers and consumers should stop using the Bronchofiberscope BF-P60 immediately. They should contact Olympus Corporation of the Americas for instructions on how to return the device or obtain a replacement.

The recalled product

Product
Bronchofiberscope BF-P60
Affected units
5,545

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 →