Quick Facts at a Glance
- Recall Date
- March 4, 2026
- Hazard Level
- HIGH
- Brand
- Koven Technology
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- PREGNANT, GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Koven Technology
- Product type
- Pocket Doppler Ultrasound Device
- Model numbers
- Lot Code: BIDOP 3 #00894912002043 BT2M20S8C #00894912002326
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
March 4, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Koven Technology, Inc. or your healthcare provider for instructions. Notification method: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
About This Product
The BiDop 3 Pocket Doppler is a handheld Doppler device used to detect blood flow and heart rate with interchangeable probes.
Why This Is Dangerous
The fetal-use labeling was not cleared under the device's 510(k), creating regulatory risk and potential misapplication.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Clinicians and patients should discontinue use of the affected devices and await recall instructions to avoid regulatory noncompliance.
Practical Guidance
How to identify if yours is affected
- Review device model ES-100V3 and BT2M20S8C probe
- Check labeling for fetal-use indication
- Verify 510(k) clearance status for fetal indication
Where to find product info
Refer to the FDA enforcement recall page and the manufacturer notice for identifiers and instructions
What timeline to expect
Remedies may be provided after recall processing; typical timelines are defined by the manufacturer and regulatory agencies
If the manufacturer is unresponsive
- Document outreach attempts
- Escalate to FDA recall contacts if the manufacturer is unresponsive
How to prevent similar issues
- Confirm clearance status for any fetal-use labeling before procurement
- Choose devices with explicit, cleared fetal indications
- Verify 510(k) clearance with the manufacturer
Documentation advice
Keep the recall notice, model numbers, lot codes, and correspondence with the manufacturer for records
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Product Details
Device: BiDop 3 Pocket Doppler ES-100V3. Fetal probe: BT2M20S8C (2 MHz). Quantity recalled: 34. Distribution: US nationwide in LA, NC, MT, TX, MA, OR, NY, IL, CO, GA, FL, WA, WI, MO, AZ, IN. Recall date: 2026-03-04. Manufacturer: Koven Technology, Inc.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Device ES-100V3 with BT2M20S8C probe
- 2 MHz fetal probe
- Nationwide US distribution across 16 states
- Fetal indication labeling not cleared under 510(k)
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Safety Guide
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