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.

Class II

Recalling firm: Koven Technology, Inc.
Reason for recall: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Affected products (lot / model / serial): Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Units affected: 34
Distribution pattern: US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Firm location: Saint Louis, MO, United States
Recall type: Voluntary: Firm initiated
How the firm notified customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Product type: Devices
Status: Ongoing
Recall number: Z-1631-2026
Recall initiated: March 4, 2026
FDA classification date: March 24, 2026
FDA report date: April 1, 2026
FDA event ID: 98556
Last updated on HTM Vibe: July 24, 2026