Aomori Olympus Co., Ltd.: Medical Device Recall in 2021 - (Recall #: Z-1060-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no. NA-201SX-4022-A - Product Usage: Used with ultrasound endoscopes for ultrasound guided fine needle aspiration of submucosal and extramural lesions of the tracheobronchial tree and esophagus.

Product Classification:

Class II

Date Initiated: January 4, 2021

Date Posted: February 17, 2021

Recall Number: Z-1060-2021

Event ID: 87074

Reason for Recall:

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.

Status: Terminated

Product Quantity: 7,400,000 (globally); 260,395 (US)

Code Information:

01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 96V, 97V, 98V, 99V, 9XV, 9YV, 9ZV, 01V, 02V, 03V, 04V, 05V, 06V, 07V, 08V, 09V, 0XV

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated