Monarch Medical Technologies EndoTool IV — Class II medical device recall Z-1786-2019
Ongoing recall by Monarch Medical Technologies, reported 2019-06-26, distributed nationwide. Insulin dosing calculations were erroneously high.
| Recall number | Z-1786-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monarch Medical Technologies, Charlotte, NC, United States |
| Recall initiated | 2019-05-03 |
| Classified | 2019-06-15 |
| Reported by FDA | 2019-06-26 |
| Distributed | Nationwide (US) |
| Quantity | 83 downloads |
Product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Reason for recall
Insulin dosing calculations were erroneously high.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1786-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.