Koven Technology recalled 34 BiDop 3 Pocket Dopplers with BT2M20S8C fetal probes nationwide after regulators found the fetal indication on the labeling was not cleared under 510(k). The defect is labeling that misrepresents fetal use. Healthcare providers and patients should stop using the devices and follow recall instructions from the manufacturer.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
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
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The BiDop 3 Pocket Doppler is a handheld Doppler device used to detect blood flow and heart rate with interchangeable probes.
The fetal-use labeling was not cleared under the device's 510(k), creating regulatory risk and potential misapplication.
This recall is not described as part of a broader industry pattern in the notice.
Clinicians and patients should discontinue use of the affected devices and await recall instructions to avoid regulatory noncompliance.
Refer to the FDA enforcement recall page and the manufacturer notice for identifiers and instructions
Remedies may be provided after recall processing; typical timelines are defined by the manufacturer and regulatory agencies
Keep the recall notice, model numbers, lot codes, and correspondence with the manufacturer for records
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.
No injuries or incidents have been reported.
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