Brand Name: BiDop 3 recallZ-1631-2026 · Koven Technology, Inc. · initiated Mar 4, 2026
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Koven Technology, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
FDA root cause category: Labeling Change Control
What the company is doing
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.
Recall details
- Recall number
- Z-1631-2026
- Status
- Open, Classified
- Initiated by the company
- Mar 4, 2026
- Posted by the FDA
- Mar 24, 2026
- Recalling firm
- Koven Technology, Inc.
- Quantity
- 34
- Product code
- DPW
- FDA submissions
- K954397
- Distribution
- US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Product description
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.
Code information (models, lots, serial numbers)
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page