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FDAMarch 31, 2023device

To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A

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

The hazard

Product non-conformance pertaining to the angle of the needle does not meet manufacturing specifications and remained unbent, resulting to slight resistance experienced during needle advancement and retraction.

What to do

FDA enforcement status: Ongoing

Brands named

olympus

UPCs

04953170388286

Recall history

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

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To be used with ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree and the gastrointestinal tract Models: NA-U401SX-4022, NA-U401SX-4022-A — Recall Details · AllClear