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.
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 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
- Affected units
- 10,801
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.
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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