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Koven Technology, Inc. recalls Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E
Recalled April 1, 2026 · FDA recall Z-1631-2026 · Koven Technology
Hazard
Product labeling includes a fetal indication for use that is not cleared under its 510(k). · FDA Class II
Units
34
Sold at
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Description
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
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.
Manufacturer(s)
Koven Technology, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →