The Recall Desk
ModerateFDA (Devices)·Z-3297-2018·Announced 2018-10-10

Olympus Bronchovideoscope BF-P180 Recalled for Instrument Channel Port Loosening

Olympus is recalling 3,705 Bronchovideoscope BF-P180 units because non-Olympus accessories may have caused the instrument channel port to loosen.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or deaths. The hazard is a mechanical defect (loosening port) without reported adverse health consequences, fitting the Moderate criteria for a precautionary recall of a medical device.

Plain-English summary

Olympus Corporation of the Americas is recalling 3,705 units of the Bronchovideoscope BF-P180. 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.

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

Healthcare facilities and users should stop using the affected Bronchovideoscope BF-P180 units and contact Olympus Corporation of the Americas for instructions on how to proceed with the recall.

The recalled product

Product
Bronchovideoscope BF-P180
Affected units
3,705

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 →