Class 2 Device Recall BiDop 3

• Date Initiated by Firm: March 04, 2026
• Date Posted: March 24, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1631-2026
• Recall Event ID: 98556
• 510(K)Number: K954397
• Product Classification: Flowmeter, blood, cardiovascular - Product Code DPW
• 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.
• Code Information: Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
• FEI Number: 1937397
• Recalling Firm/ Manufacturer: Koven Technology, Inc.; 477 N Lindbergh Blvd Ste 220; Saint Louis MO 63141-7856
• For Additional Information Contact: Heather Bell; 001-800-5218342
• Manufacturer 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: 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = DPW