HIGHFDA DEVICE
Koven Technology BiDop 3 Pocket Doppler ES-100V3 Recalled for Fetal Labeling Issue (2026)
Koven Technology recalled 34 BiDop 3 Pocket Dopplers with BT2M20S8C fetal probes nationwide after regulators found the fetal indication on the labeling was not cleared under 510(k). The defect is labeling that misrepresents fetal use. Healthcare providers and patients should stop using the devices and follow recall instructions from the manufacturer.
Koven Technology
Product labeling