Koven recalls BiDop 3 Pocket Doppler (ES-10:100V3) with BT2M20S8C fetal probe due to unapproved fetal use labeling. This device is intended for vascular blood flow detection, not fetal applications.
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
Koven is recalling its BiDop 3 Pocket Doppler ultrasound device because it's labeled for fetal use without FDA clearance. This means the device could be used incorrectly for fetal monitoring, which might lead to inaccurate readings or harm.
The device is labeled for both vascular and fetal use, but the FDA only cleared it for vascular blood flow detection. Using it for fetal monitoring without proper clearance could lead to inaccurate readings or potential harm to the fetus.
Pregnant women and healthcare providers using the BiDop 3 Pocket Doppler with the BT2M20S8C fetal probe for fetal monitoring. Those who have the specific model and lot codes are most at risk.
Check for the model number ES-100V3 on the device and lot code BIDOP 3 #00894912002043 or BT2M20S8C #00894912002326. The device comes with a 2 MHz fetal probe labeled for both vascular and fetal applications.
Look for the model number ES-100V3 and lot code BIDOP 3 #00894912002043 or BT2M20S8C #00894912002326 on the device.
No, the device is not cleared by the FDA for fetal monitoring. It is intended only for vascular blood flow detection.
Check the device label for the model number and lot code. If it matches the recalled units, contact Koven for guidance.
The device was labeled for fetal use without FDA clearance, which could lead to inaccurate readings or potential harm to the fetus.
We’ve drafted a message you can send Koven to request your refund or repair — edit it as you like.
Subject: Recall Z-1631-2026 — Koven Koven Hello, I own a Koven that is covered by recall Z-1631-2026 from Koven. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
