Olympus Tracheal Intubation Fiberscope may lodge in endotracheal tube connector
Olympus tracheal intubation fiberscope models LF-DP, LF-GP, and LF-TP are being recalled because the endoscope can become lodged in the endotracheal tube connector due to an 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 an FDA Class II recall of a medical device where the endoscope can become lodged in an endotracheal tube connector, creating a risk of airway management complications. No illnesses or injuries have been reported in the source documentation.
Plain-English summary
Olympus Corporation of the Americas is recalling the Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, and LF-TP. Approximately 10,801 units have been distributed nationwide. All serial numbers of the affected models are included in this recall.
The endoscope can become lodged in the endotracheal tube connector because the endoscope diameter is too large. This issue was identified through a complaint filed with the FDA. A lodged endoscope could interfere with proper airway management during intubation procedures.
Affected healthcare facilities and medical practitioners should verify whether they have received these devices and contact Olympus Corporation of the Americas for further information regarding this recall.
The recalled product
- Product
- Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP.
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- device-lodging
- airway-obstruction
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 (7)
- UDI-DI: 04953170136856
- 04953170340192
- 04953170061998
- 04953170340215
- 04953170317576
- & 04953170136825
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
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