Saint Louis, MO, United States
Koven Technology, Inc. recalls
1 recall recorded since 2018, most recently on 4 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 4 March 2026
- Reason
- Product labeling includes a fetal indication for use that is not cleared under its 510(k).
- Distribution
- US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1631-2026
- Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: ES-100V3 (device); BT2M20S8C (2 MHz fetal probe). Software Version: N/A Product Description: Hand-h
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.