The Recall Desk
HighFDA (Devices)·Z-3299-2018·Announced 2018-10-10

Olympus Bronchofiberscope BF-P40 Recalled for Instrument Channel Port Loosening

Olympus is recalling 5,607 Bronchofiberscope BF-P40 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 medical device with a structural defect that could lead to device failure during use, representing a risk of harm where specific injuries have not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 5,607 units of the Bronchofiberscope BF-P40. The recall covers all lot codes and includes products distributed in the United States and Canada.

The recall is due to a potential defect where 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 providers and consumers should stop using the affected devices and contact Olympus Corporation of the Americas for further instructions on the recall.

The recalled product

Product
Bronchofiberscope BF-P40
Affected units
5,607

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 →