FDA Device recall Z-1038-2021
NEEDLEMASTER 6MMx 23G UPPER, model no
- FDA Device
- Class II
- terminated
- Published 2021-02-17
On 2021-02-17 the FDA classified a Class II recall of NEEDLEMASTER 6MMx 23G UPPER, 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-1038-2021 |
| 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
NEEDLEMASTER 6MMx 23G UPPER, model no. NM-610L-0623 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract.
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 | 05K, 06K, 07K, 08K, 09K, 0XK, 98K, 9XK, 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-1038-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.