Olympus Corporation of the Americas: Medical Device Recall in 2023 - (Recall #: Z-1616-2023)

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:

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

Product Classification:

Class III

Date Initiated: March 31, 2023

Date Posted: May 31, 2023

Recall Number: Z-1616-2023

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: 1297 (Boxes; 5 per Box)

Code Information:

UDI: 04953170388286 Lot numbers: KR248740 KR248746 KR252863 KR253666 KR253681 KR260854 KR260865 KR260873 KR260875 KR260876 KR260877 KR260896 KR260917 KR260937

Distribution Pattern:

Natiowide Foreign: Canada, Germany

Voluntary or Mandated:

Voluntary: Firm initiated