The Recall Desk
HighFDA (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.

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
Hazard
  • equipment-lodging
  • mechanical-defect

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.