FDA Device recall Z-1786-2019
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10
- FDA Device
- Class II
- ongoing
- Published 2019-06-26
On 2019-06-26 the FDA classified a Class II recall of Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10 by Monarch Medical Technologies, citing insulin dosing calculations were erroneously high.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1786-2019 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-05-03 |
| Published | 2019-06-26 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Monarch Medical Technologies |
| Distribution | US |
Product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Reason
Insulin dosing calculations were erroneously high.
Identifiers
| code_info | Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1786-2019%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.