Koven Technology, Inc. recalls Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler
- Recalling company
- Koven Technology, Inc.
- Product
- 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-held, battery-powered ultrasonic Doppler blood-flow detector with LCD numeric display, used with interchangeable probes to detect vascular blood-flow signals and display heart rate; affected units were packaged with a 2 MHz BT2M20S8C fetal probe and labeled for both vascular and fetal applications.
- Reason
- Product labeling includes a fetal indication for use that is not cleared under its 510(k).
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Mar 4, 2026
- Reported
- Apr 1, 2026
- Distribution
- US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
- Status
- Ongoing
- Quantity
- 34
- Lot / codes
- Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
- Company location
- Saint Louis, MO
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1631-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1631-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.