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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.
Why it was recalled
Product labeling includes a fetal indication for use that is not cleared under its 510(k).
How to identify it
UPC 00894912002043 00894912002326
Where it was sold
Distributed in US.
Official source
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Editorial summary by Recall Canary · last updated 2026-06-05 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification