Recall Z-1615-2023— Olympus Corporation of the Americas

Name: FDA recall Z-1615-2023
Creator: U.S. Food and Drug Administration
Published: 2023-03-31

Class III · Ongoing

Class III FDA medical device recall by Olympus Corporation of the Americas, initiated 2023-03-31. It names one FDA 510(k) clearance: K160098. Product: ViziShot 2 Single Use Aspiration Needle, 21G- 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. Model: NA-U401SX-4021, NA-U401SX-4021-A. Reason: 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..

Recalling firm: Olympus Corporation of the Americas
Classification: Class III
Status: Ongoing
Initiated: 2023-03-31
Firm location: Center Valley, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K160098 — Single Use Aspiration Needle NA-U401SXOlympus Medical Systems Corp.·cleared 2016-03-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

ViziShot 2 Single Use Aspiration Needle, 21G- 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. Model: NA-U401SX-4021, NA-U401SX-4021-A

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.