Agency classClass IIOur severity:High FDA (Devices)·Z-2501-2023·Announced 2023-09-06

Olympus Tracheal Intubation Fiberscope Recalled Due to Lodging Risk

Olympus Corporation recalls Tracheal Intubation Fiberscope Models LF-P and LF-V nationwide. The device can become lodged in the endotracheal tube connector due to oversized diameter.

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 Class II recall of a medical device with a mechanical defect that could interfere with intubation procedures. No injuries or hospitalizations have been reported, placing it in the 'risk-of-harm' category without documented harm.

Plain-English summary

Olympus Corporation of the Americas is recalling Tracheal Intubation Fiberscope Models LF-P and LF-V. A total of 2,127 units have been distributed nationwide to healthcare facilities.

The recalled devices may become lodged in the endotracheal tube connector due to the endoscope diameter being too large. This mechanical defect could interfere with proper intubation procedures.

Healthcare facilities and medical professionals currently using these fiberscope models should discontinue use and contact Olympus Corporation of the Americas for instructions regarding device replacement or return. The recall affects all units identified by UDI-DI numbers 04953170051098, 04953170452932, and 04953170156250 and all serial numbers of Models LF-P and LF-V.

The recalled product

Product: Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Tracheal Intubation Endoscope
Hazard: equipment-lodging
mechanical-defect
Affected units: 2,127

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 (4)

UDI-DI: 04953170051098
04953170452932
& 04953170156250
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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