The Recall Desk
ModerateFDA (Devices)·Z-3293-2018·Announced 2018-10-10

Olympus Bronchofibercope BF-6C240 Recalled for Instrument Channel Port Loosening

Olympus is recalling 197 Bronchofibercope BF-6C240 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, and the source text describes a mechanical defect (loosening of the port) without reporting any specific injuries, illnesses, or fatalities, fitting the criteria for a moderate severity recall.

Plain-English summary

Olympus Corporation of the Americas is recalling 197 units of the Bronchofibercope BF-6C240. 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 includes all lot codes for this specific model.

Healthcare providers and consumers should stop using the affected bronchoscopes and contact Olympus Corporation of the Americas for further instructions on how to proceed.

The recalled product

Product
Bronchofibercope BF-6C240
Affected units
197

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 →