Agency classClass IIOur severity:High FDA (Devices)·Z-2493-2023·Announced 2023-09-06

Olympus Bronchovideoscope Models Recalled for Endotracheal Tube Connector Lodging Risk

Olympus is recalling 3,652 bronchovideoscope units nationwide due to complaints that the endoscope diameter is too large, creating a risk the scope may become lodged in the endotracheal tube connector.

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: This is a risk-of-harm medical device where the endoscope may become lodged in the airway connector, potentially compromising patient safety. No illnesses or injuries have been reported, which aligns with FDA Class II classification and the rubric criterion for High severity.

Plain-English summary

Olympus Corporation of the Americas is recalling Olympus Bronchovideoscope Models BF-1T180, BF-1TQ180, BF-P180, and BF-Q180. These devices were distributed nationwide in the United States, with approximately 3,652 units affected.

The recall was issued due to complaints that the endoscope diameter is oversized, creating a risk that the endoscope may become lodged in the endotracheal tube connector during clinical use.

Healthcare facilities and providers who use these bronchovideoscopes should stop using the affected models immediately. Patients who received care using these devices should consult their healthcare provider if they have concerns. The manufacturer recommends contacting Olympus Corporation of the Americas for instructions on device return or replacement.

The recalled product

Product: Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device
Hazard: device-lodging
airway-obstruction
Affected units: 3,652

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 (13)

UDI-DI: 04953170308215
04953170288975
04953170339325
04953170308222
04953170289002
04953170339349
04953170308192
04953170317965
04953170339288
04953170288883
04953170308208
04953170288937
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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Same hazard · device lodging