EndoTool SubQ — Class II medical device recall Z-0354-2020
Terminated recall by Monarch Medical Technologies, reported 2019-11-20, distributed in CA, IL, IN, SC. Product was distributed prior to approval or clearance from FDA.
| Recall number | Z-0354-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Monarch Medical Technologies, Charlotte, NC, United States |
| Recall initiated | 2019-10-01 |
| Classified | 2019-11-08 |
| Reported by FDA | 2019-11-20 |
| Terminated | 2026-02-10 |
| Distributed | CA, IL, IN, SC |
| Quantity | 6 units |
Product
EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Reason for recall
Product was distributed prior to approval or clearance from FDA.
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-0354-2020. 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.