FDA Device recall Z-1060-2021
NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of NA-201SX-4022-ASPIRATION NEEDLE VIZISHOT 22G, model no by Aomori Olympus, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1060-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-01-04 |
| Published | 2021-02-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Aomori Olympus |
| Distribution | US |
Product
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.
Reason
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.
Identifiers
| code_info | 01K, 02K, 03K, 04K, 05K, 06K, 07K, 08K, 09K, 0XK, 92K, 93K, 94K, 95K, 96K, 97K, 98K, 99K, 9XK, 9YK, 9ZK, 05V, 96V, 97V,…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1060-2021%22
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