FDA recall, , Moderate risk
BiDop 3 Pocket Doppler Blood-Flow Detectors
The BiDop 3 Pocket Doppler has a fetal indication for use that is not cleared.
Summary by Recall Canary from the FDA notice
What happened
Koven Technology, Inc., of Saint Louis, Missouri, recalled the BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe because its product labeling includes a fetal indication for use that is not cleared under its 510(k). The recall began March 4, 2026, and was added to the FDA's Enforcement Report on March 24, 2026.
The device is a 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 use.
The device was distributed nationwide in states including Louisiana, North Carolina, Montana, Texas, Massachusetts, Oregon, New York, Illinois, Colorado, Georgia, Florida, Washington, Wisconsin, Missouri, Arizona, and Indiana.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the listed under your product.
BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of Louisiana, North Carolina, Montana, Texas Massachusetts, Oregon, New York, Illinois, Colorado, Georgia, Florida, Washington, Wisconsin, Missouri, Arizona, Indiana.
- Company
- Koven Technology, Inc.Saint Louis, Missouri
- Hazard
- Unapproved product
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98556
- Recall number
- Z-1631-2026
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
