Recall Z-1631-2026
Koven Technology, Inc. · initiated March 4, 2026
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Reason for recall
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
FDA-determined cause: Labeling Change Control
Action taken
On March 4, 2026, firm began notifying customers via first-class mail. Customers were informed they may still use the BiDop 3 device for vascular applications, but that the device is not cleared for fetal usage. Koven Technology, Inc. will provide a replacement operation manual for devices that are being amended to remove fetal use indications.
Details
- Recall number
- Z-1631-2026
- Initiated
- March 4, 2026
- Posted by FDA
- March 24, 2026
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Quantity
- 34
- Distribution
- US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
- Recalling firm
- Koven Technology, Inc., Saint Louis, MO