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BiDop 3 Pocket Doppler
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MEDICAL DEVICE RECALLMODERATE

BiDop 3 Pocket Doppler

Koven Technology is recalling the BiDop 3 Pocket Doppler due to unauthorized fetal indication labeling.

What to do

Stop using the device for fetal heart rate monitoring immediately. Contact Koven Technology for updated labeling or further instructions regarding the device's intended use.

Recalled
Listed
Updated
Recall No.
Z-1631-2026
Agency
FDA
Firm
Koven Technology, Inc.
Recall ID
98556
Status
ONGOING

Why it was recalled

Koven Technology is recalling the BiDop 3 Pocket Doppler because the product labeling includes a fetal indication for use that has not received 510(k) clearance. The affected units were packaged with a 2 MHz fetal probe and labeled for both vascular and fetal applications.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probeModel/Catalog number: ES-100V3 (device), BT2M20S8C (2 MHz fetal probe)

UDI-DI
00894912002043, 00894912002326
–

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-06-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification