Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog Number: E
Summary
The FDA issued a Class II for Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20 by Koven Technology, Inc.. Reason: Product labeling includes a fetal indication for use that is not cleared under its 510(k)..
Details
Source
Device Recall
External ID
Z-1631-2026
Action Date
2026-04-01
Status
Ongoing
Category
device
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.
Lot/Code Info: Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
Quantity Affected: 34
Reason for Recall
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Distribution
US Nationwide distribution in the states of LA, NC, MT, TX MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-04
Company
Saint Louis, MO
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 161 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Koven Technology, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Koven Technology, Inc. have FDA actions?
This is the only FDA action we have on record for Koven Technology, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-1631-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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