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FDASeptember 25, 2023device

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.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Channel air drying process was not validated, and that a small percentage of scopes returned to customers after repair had a wet channel. Water remaining in the channel of the endoscopes has the potential for contamination that could lead to the risk of infection

What to do

FDA enforcement status: Ongoing

Brands named

aizu olympusaizu

UPCs

049531703071880495317033950904953170411526

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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