Agency classClass IIOur severity:High FDA (Devices)·Z-3305-2018·Announced 2018-10-10

Olympus Bronchovideoscope BF-XP160F Recalled for Instrument Channel Port Loosening

Olympus is recalling 1,461 Bronchovideoscope BF-XP160F units because using non-Olympus accessories may cause the instrument channel port to loosen.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 is classified as FDA Class II. The hazard involves a structural defect (loosening of the instrument channel port) in a medical device, which poses a risk of harm during use, but the source text does not report any specific injuries or illnesses.

Plain-English summary

Olympus Corporation of the Americas is recalling 1,461 units of the Bronchovideoscope BF-XP160F. 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 covers all lot codes for this specific model. The source text does not specify a particular date range for distribution or identify specific healthcare facilities affected.

Healthcare providers and consumers should stop using the affected Bronchovideoscope BF-XP160F units immediately. Users should contact Olympus Corporation of the Americas for instructions on how to return the device or obtain a replacement. Do not use non-Olympus accessories with this device to prevent further damage to the instrument channel port.

The recalled product

Product: Bronchovideoscope BF-XP160F
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopy
Hazard: structural-defect
device-malfunction
Affected units: 1,461

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 →

Same manufacturer · Olympus Corporation of the Americas

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