Charlotte, NC, United States
Monarch Medical Technologies recalls
2 recalls recorded since 2018, most recently on 1 October 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 1 October 2019
- Terminated
- 10 February 2026
- Reason
- Product was distributed prior to approval or clearance from FDA.
- Distribution
- SC, IL IN, CA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0354-2020
- EndoTool SubQ (Versions 1.7.1, 1.7.4, 1.7.5)
Ongoing Class II Medical devices
- Recall started
- 3 May 2019
- Reason
- Insulin dosing calculations were erroneously high.
- Distribution
- Nationwide and Dubai
- Initiated
- Voluntary: Firm initiated
- Recall number
- 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.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.