FDA Device recall Z-0354-2020
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
- FDA Device
- Class II
- terminated
- Published 2019-11-20
On 2019-11-20 the FDA classified a Class II recall of EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5) by Monarch Medical Technologies, citing product was distributed prior to approval or clearance from FDA.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0354-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-10-01 |
| Published | 2019-11-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Monarch Medical Technologies |
| Distribution | CA, IL, IN, SC |
Product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Reason
Product was distributed prior to approval or clearance from FDA.
Identifiers
| code_info | versions: v 1.7.1, 1.7.4, 1.7.5 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2020%22
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