FDA-Device2026-04-01Class IIMISBRANDING
Koven BiDop 3 Pocket Doppler recalled for unauthorized fetal use labeling
FALSE CLAIMSNationwide distribution
Stop using Koven BiDop 3 Pocket Doppler
Koven Technology's BiDop 3 Pocket Doppler ultrasound device was distributed with labeling that claims it can be used for fetal applications, but the FDA never approved it for that use. The device is only cleared to detect blood flow in blood vessels, not for fetal monitoring. Using it for unapproved purposes could lead to incorrect results or missed diagnoses.
- Stop using the BiDop 3 for any fetal applications immediately
- Contact Koven Technology or your distributor about returning the device
- Check your device packaging for lot numbers #00894912002043 (ES-100V3) or #00894912002326 (BT2M20S8C probe)
- Use only cleared ultrasound devices for fetal monitoring under medical supervision
Hazard
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Sold states
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Affected count
34
Manufactured in
477 N Lindbergh Blvd Ste 220, Saint Louis, MO, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1631-2026Don't want to check this manually?
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