Transnasal Esophagovideoscope Recalled Due to Unvalidated Drying Process
Aizu Olympus is recalling the Transnasal Esophagovideoscope (Model PEF-V) because the channel air drying process was not validated, resulting in some units with wet channels that could cause infection.
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 recall involving a medical device used in internal procedures. The hazard—water contamination leading to potential infection—is theoretical with no reported illnesses or injuries, placing it at the High severity level per the rubric.
Plain-English summary
Aizu Olympus Co., Ltd. is recalling the Transnasal Esophagovideoscope, Model PEF-V, used for endoscopy and endoscopic surgery within the esophagus and stomach. The recall involves 25 units distributed nationwide in the United States.
The company discovered that the channel air drying process was not adequately validated. A small percentage of scopes returned to customers after repair retained water in the channels. Water remaining in the endoscope channels could become contaminated and potentially lead to infection.
Healthcare facilities using this equipment should contact Aizu Olympus Co., Ltd. regarding the recall.
The recalled product
- Product
- Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the esophagus and stomach. Model Number: PEF-V.
- Manufacturer
- Aizu Olympus Co., Ltd.
- Affected units
- 25
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): PEF-V (04953170340376).
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.
See all 22 products in this recall →Related recalls
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