Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-1615-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class III

Date Initiated: March 31, 2023

Date Posted: May 31, 2023

Recall Number: Z-1615-2023

Event ID: 92129

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.

Status: Ongoing

Product Quantity: 2058 (Boxes; 5 per Box)

Code Information:

UDI: 04953170388248 Lot numbers: KR243729 KR248648 KR248652 KR248673 KR248784 KR248785 KR248808 KR249160 KR251593 KR257313 KR257314 KR264662 KR264697 KR264708 KR264711 KR264726 KR264732 KR264746 KR264751 KR264778 KR264806 KR276770

Distribution Pattern:

Natiowide Foreign: Canada, Germany

Voluntary or Mandated:

Voluntary: Firm initiated