Rhinolaryngoscope Models Recalled for Unvalidated Air Drying Process
Aizu Olympus rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) are recalled. The air-drying process for the instrument channel was not validated, and water remaining in some devices after repair poses contamination and infection risk.
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: FDA Class II medical device recall involving potential contamination and infection risk from an unvalidated drying process. No illnesses or injuries have been reported; however, the contamination risk in a sterile medical device application meets criteria for High severity.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling rhinolaryngoscopes (models ENF-T3, ENF-VT2, ENF-VT3) used for endoscopic diagnosis and treatment within nasal lumens and airway anatomy. Approximately 46 units have been distributed in the United States and worldwide.
The channel air-drying process used on these devices was not validated. As a result, a small percentage of scopes returned to customers after repair contained water remaining in the channel. Water in the channel presents a potential for contamination that could lead to the risk of infection.
The recalled product
- Product
- Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lumens and airway anatomy (including nasopharyngeal and trachea). Model Numbers: ENF-T3, ENF-VT2, ENF-VT3.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 46
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 (3)
- Model Number (UDI-DI): ENF-T3 (04953170307188)
- ENF-VT2 (04953170339509)
- ENF-VT3 (04953170411526).
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 22 recalled by Aizu Olympus Co., Ltd. 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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