FDA Medical devices recall ·
BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C… recall
- Recall number
- Z-1631-2026
- Date
- (initiated March 4, 2026)
- Company / brand
- Koven Technology, Inc.
477 N Lindbergh Blvd Ste 220, Saint Louis, MO, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 34
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Distribution
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
States: Arizona Colorado Florida Georgia Illinois Indiana Louisiana Massachusetts Missouri Montana North Carolina New York Oregon Texas Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1631-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.