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FDAJanuary 4, 2021device

NA-201SX-4021 ASPIRATION NEEDLE VIZISHOT 21G, model no. NA-201SX-4021 - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

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

The hazard

Inspection confirmed a small percentage of sterile packages with inadequate package seal (partial heat seal). Patients may develop infections if non-sterile equipment is used.

What to do

FDA enforcement status: Terminated

Brands named

aomori olympusaomori

Recall history

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

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