Recall Z-1631-2026 ยท DPW Flowmeter, Blood, Cardiovascular
Koven Technology, Inc.
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; aff
| Date | Mar 24, 2026 (initiated Mar 4, 2026) |
| Status | Open, Classified |
| Reason | Product labeling includes a fetal indication for use that is not cleared under its 510(k). |
| Root cause | Labeling Change Control |
| Action | 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. |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954397 | BIDIRECTIONAL DOPPLER W/WAVEFORM DISPLAY Koven Technology, Inc., Mar 29, 1996 |