Reported Apr 1, 2026 · Ongoing
Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number:…
Koven Technology, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Koven Technology, Inc. · 477 N Lindbergh Blvd Ste 220 · Saint Louis, MO · 63141-7856
Is this the product you have?
- Brand NameBiDop 3
- Product NameBiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C
- fetal probe Model/Catalog Number
ES-100V3 (device)BT2M20S8C (2 MHz fetal probe)
- Software VersionN/A
- Product DescriptionHand-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
- Lot codes and dates
- Lot CodeBIDOP 3 #00894912002043 BT2M20S8C #00894912002326
- Amount recalled
- 34
Where it was sold
Why it was recalled
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
This product could cause temporary or reversible health problems — stop using it.
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