Agency classClass IIOur severity:High FDA (Devices)·Z-2500-2023·Announced 2023-09-06

Olympus Bronchovideoscope Models Risk Device Lodging in Airway

Olympus Corporation is recalling 3,949 Bronchovideoscope units nationwide because the endoscope diameter is too large, causing potential lodging in endotracheal tube connectors.

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 addresses a mechanical sizing hazard with no reported injuries or deaths. FDA Class II classification with theoretical risk of device lodging but no documented adverse events justifies Score 3 under the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'

Plain-English summary

Olympus Corporation of the Americas is recalling 3,949 Bronchovideoscope units, Models BF-P190 and BF-XP190, distributed nationwide. These devices are identified by UDI-DI numbers 04953170342110, 04953170434983, 04953170342134, and 04953170434990, including all serial numbers of these models.

The devices are being recalled because the endoscope diameter is too large, which causes the device to become lodged in endotracheal tube connectors. This mechanical sizing defect creates a risk of device entrapment during clinical use.

Healthcare facilities and medical professionals currently using these Bronchovideoscope models may be affected. Users of these devices should verify their inventory against the recalled model and serial numbers.

The U.S. Food and Drug Administration has assigned recall number Z-2500-2023 to this action.

The recalled product

Product: Olympus Bronchovideoscope, Models BF-P190 & BF-XP190.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscopy / Bronchoscopy
Hazard: device-lodging
sizing-defect
Affected units: 3,949

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 (5)

UDI-DI: 04953170342110
04953170434983
04953170342134
& 04953170434990
All Serial Numbers.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 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 15 products in this recall →

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