Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler recall (Koven Technology, Inc.)
Medical deviceClass IIOngoing
Summary: Koven Technology, Inc. is recalling 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 dis. Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k).
What is being recalled
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.
Why
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN. (states named: Arizona, Colorado, Florida, Georgia, Illinois, Indiana, Louisiana, Massachusetts, Missouri, Montana, North Carolina, New York, Oregon, Texas, Washington, Wisconsin)
How to tell if yours is affected
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1631-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 4, 2026 |
| Reported | April 1, 2026 |
| Company | Koven Technology, Inc. |
| Company location | Saint Louis, MO, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 34 |
More recalls from Koven Technology, Inc. · all medical device recalls · recalls from March 2026