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.
What this means for you
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
- 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.
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