WhichRecall
Class IIReported 2026-04-01

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.

Recalled by Koven Technology, Inc.

Reason for Recall

Product labeling includes a fetal indication for use that is not cleared under its 510(k).

Advertisement
Recall Number
Z-1631-2026
Classification
Class II
Status
Ongoing
Category
device
Initiated
2026-03-04
Reported
2026-04-01
Distribution
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Code Info
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
Advertisement