Tracheal Videoscope Recall Due to Unvalidated Drying Process
Aizu Olympus is recalling 61 tracheal videoscopes (Model LF-V) due to an unvalidated air drying process that left water in channels after repair. Water in the endoscope channels may become contaminated and pose an infection risk.
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: FDA Class II medical device with potential for contamination and infection risk. No reported illnesses or injuries, and the hazard is theoretical. This qualifies as severity score 3 per the rubric.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling 61 tracheal videoscopes, Model Number LF-V (UDI-DI: 04953170340246). These devices are used for airway management, including observation to access airway anatomy and for endotracheal/endobronchial intubation and management.
The air drying process used after repair was not validated. As a result, a small percentage of scopes returned to customers after repair had water remaining in the channels. Water in the endoscope channels may become contaminated and pose a risk of infection.
The affected devices were distributed nationwide and worldwide. Customers who have questions about this recall should contact Aizu Olympus Co., Ltd.
The recalled product
- Product
- Tracheal videoscope- For airway management, which includes observation to access airway anatomy, endotracheal/endobronchial intubation and management. Model Number: LF-V.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Hazard
- contamination
- infection-risk
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 (1)
- Model Number (UDI-DI): LF-V (04953170340246)
Distribution
Distributed nationwide across the United States.
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